Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02710669
Status:
TERMINATED
Last Update Posted:
2022-06-03
First Post:
2016-03-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
New Formulations of Propafenone to Treat Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011405', 'term': 'Propafenone'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'moore.b.shoemaker@vumc.org', 'phone': '615-322-2318', 'title': 'Benjamin Shoemaker, MD', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was collected the day of procedure only', 'description': "Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': '(R)-Propafenone', 'description': 'Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes\n\n(R)-propafenone', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '(S)-Propafenone', 'description': 'Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes\n\n(S)-Propafenone', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo (normal saline) is infused over 10 minutes\n\nPlacebo', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Successful Induction of 30 Seconds of Atrial Fibrillation/Atrial Flutter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(R)-Propafenone', 'description': 'Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes\n\n(R)-propafenone'}, {'id': 'OG001', 'title': '(S)-Propafenone', 'description': 'Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes\n\n(S)-Propafenone'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (normal saline) is infused over 10 minutes\n\nPlacebo'}], 'classes': [{'title': 'Sustained AF and/or AFL induced', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Non-sustained AF and/or AFL induced', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)', 'description': 'A rapid atrial pacing protocol was used to attempt to induce atrial fibrillation/atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial fibrillation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "27 Participants not analyzed as follows: R GROUP: (1) prolonged pharmacy time compounding the study med; (8) arrived in atrial fib/flutter; (1) physician withdrew due to PAC's; (1) took antiarrhythmic prior to ablation; (1) difficult anatomy (1) ischemia on MRI; (1) Due to COVID the lab halted elective research. S GROUP: (7) arrived in afib; (1) clot on TEE; (1) elevated anxiety in patient; (1) procedure scheduled late in day; (1) cardiac cath work-up needed. PLACEBO GROUP: (2) arrived in afib"}, {'type': 'SECONDARY', 'title': 'Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(R)-Propafenone', 'description': 'Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes\n\n(R)-propafenone'}, {'id': 'OG001', 'title': '(S)-Propafenone', 'description': 'Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes\n\n(S)-Propafenone'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (normal saline) is infused over 10 minutes\n\nPlacebo'}], 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Non-inducible AF/AFL', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)', 'description': 'Inducibility of atrial fibrillation (AF) or atrial flutter (AFL) expressed as an ordinal variable based on stage of the induction protocol.\n\n* Stage 1 measured the AV block (Wenckebach) cycle length (AVBCL), AV node effective refractory period (AVN ERP) and atrial ERP (AERP). AVN ERP and AERP were measured at drive trains (S1) of 600 ms and 450 ms. Extrastimuli (S2) were introduced starting at a coupling interval of 500ms and decremented by 10ms with each pacing train.\n* Stage 2 consisted of 15-beat bursts from the CS proximal electrode. The starting cycle length was 250ms, which was decremented by 10ms with each burst. A 10-second rest period was used between bursts. Step 2 was complete when 1:1 atrial capture was lost or a minimum cycle length of 180ms was reached.\n\nStage 3 consisted of 15-second bursts. The cycle length used for the bursts was the fastest cycle length achieved during Step 2 that maintained 1:1 atrial conduction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "27 Participants not analyzed as follows: R GROUP: (1) prolonged pharmacy time compounding the study med; (8) arrived in atrial fib/flutter; (1) physician withdrew due to PAC's; (1) took antiarrhythmic prior to ablation; (1) difficult anatomy (1) ischemia on MRI; (1) Due to COVID the lab halted elective research. S GROUP: (7) arrived in afib; (1) clot on TEE; (1) elevated anxiety in patient; (1) procedure scheduled late in day; (1) cardiac cath work-up needed. PLACEBO GROUP: (2) arrived in afib"}, {'type': 'SECONDARY', 'title': 'Number of Participants With Successful Induction of 30 Seconds of Atrial Flutter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '(R)-Propafenone', 'description': 'Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes\n\n(R)-propafenone'}, {'id': 'OG001', 'title': '(S)-Propafenone', 'description': 'Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes\n\n(S)-Propafenone'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (normal saline) is infused over 10 minutes\n\nPlacebo'}], 'classes': [{'title': 'Sustained AFL', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Non-Sustained AFL', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)', 'description': 'A rapid atrial pacing protocol was used to attempt to induce atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial flutter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "27 Participants not analyzed as follows: R GROUP: (1) prolonged pharmacy time compounding the study med; (8) arrived in atrial fib/flutter; (1) physician withdrew due to PAC's; (1) took antiarrhythmic prior to ablation; (1) difficult anatomy (1) ischemia on MRI; (1) Due to COVID the lab halted elective research. S GROUP: (7) arrived in afib; (1) clot on TEE; (1) elevated anxiety in patient; (1) procedure scheduled late in day; (1) cardiac cath work-up needed. PLACEBO GROUP: (2) arrived in afib"}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '(R)-Propafenone', 'description': 'Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes\n\n(R)-propafenone'}, {'id': 'FG001', 'title': '(S)-Propafenone', 'description': 'Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes\n\n(S)-Propafenone'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo (normal saline) is infused over 10 minutes\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Institutional delays (including COVID)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'arrived in afib/aflutter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '193 participants were enrolled. 1 participant withdrew consent prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '(R)-Propafenone', 'description': 'Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes\n\n(R)-propafenone'}, {'id': 'BG001', 'title': '(S)-Propafenone', 'description': 'Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes\n\n(S)-Propafenone'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo (normal saline) is infused over 10 minutes\n\nPlacebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '68'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '70'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '71'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '56', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One participant was not randomized'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-03', 'size': 594719, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-12T18:50', 'hasProtocol': True}, {'date': '2019-10-23', 'size': 912446, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-16T15:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'whyStopped': 'Study halted/terminated prematurely due to COVID.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2016-03-12', 'resultsFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-20', 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Successful Induction of 30 Seconds of Atrial Fibrillation/Atrial Flutter', 'timeFrame': 'Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)', 'description': 'A rapid atrial pacing protocol was used to attempt to induce atrial fibrillation/atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial fibrillation.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol', 'timeFrame': 'Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)', 'description': 'Inducibility of atrial fibrillation (AF) or atrial flutter (AFL) expressed as an ordinal variable based on stage of the induction protocol.\n\n* Stage 1 measured the AV block (Wenckebach) cycle length (AVBCL), AV node effective refractory period (AVN ERP) and atrial ERP (AERP). AVN ERP and AERP were measured at drive trains (S1) of 600 ms and 450 ms. Extrastimuli (S2) were introduced starting at a coupling interval of 500ms and decremented by 10ms with each pacing train.\n* Stage 2 consisted of 15-beat bursts from the CS proximal electrode. The starting cycle length was 250ms, which was decremented by 10ms with each burst. A 10-second rest period was used between bursts. Step 2 was complete when 1:1 atrial capture was lost or a minimum cycle length of 180ms was reached.\n\nStage 3 consisted of 15-second bursts. The cycle length used for the bursts was the fastest cycle length achieved during Step 2 that maintained 1:1 atrial conduction.'}, {'measure': 'Number of Participants With Successful Induction of 30 Seconds of Atrial Flutter', 'timeFrame': 'Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)', 'description': 'A rapid atrial pacing protocol was used to attempt to induce atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial flutter.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ablation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '24493699', 'type': 'BACKGROUND', 'citation': 'Faggioni M, Savio-Galimberti E, Venkataraman R, Hwang HS, Kannankeril PJ, Darbar D, Knollmann BC. Suppression of spontaneous ca elevations prevents atrial fibrillation in calsequestrin 2-null hearts. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):313-20. doi: 10.1161/CIRCEP.113.000994. Epub 2014 Feb 3.'}, {'pmid': '36166682', 'type': 'DERIVED', 'citation': 'Shoemaker MB, Yoneda ZT, Crawford DM, Akers WS, Richardson T, Montgomery JA, Phillips S, Shyr Y, Saavedra P, Estrada JC, Kanagasundram A, Shen ST, Michaud GF, Crossley G, Ellis CR, Knollmann BC. A Mechanistic Clinical Trial Using (R)- Versus (S)-Propafenone to Test RyR2 (Ryanodine Receptor) Inhibition for the Prevention of Atrial Fibrillation Induction. Circ Arrhythm Electrophysiol. 2022 Oct;15(10):e010713. doi: 10.1161/CIRCEP.121.010713. Epub 2022 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will randomize participants to (R)-propafenone, (S)-propafenone, or placebo.', 'detailedDescription': 'Atrial fibrillation is a common cardiac arrhythmia that needs development of more effective medications. Propafenone is a medicine currently used to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. The investigators have discovered that purified (R)-propafenone may be more effective than (S)-propafenone for treatment of atrial fibrillation, and that (S)-propafenone reduces the efficacy of (R)-propafenone when administered as a mixture. This study will compare the ability of (R)-propafenone, (S)-propafenone, and placebo to suppress the induction of atrial fibrillation in participants undergoing an atrial fibrillation ablation procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. History of atrial fibrillation\n2. Greater than or equal to 18 years of age\n3. Scheduled to undergo an atrial fibrillation ablation procedure\n4. Able to provide written informed consent\n\nExclusion:\n\n1. Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)\n2. Is in atrial fibrillation or atrial flutter the morning of the ablation procedure\n3. The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator\n\n 1. sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia\n 2. sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration\n 3. right bundle branch block, left bundle branch block, or bifascicular block\n 4. PR-interval \\> 280ms, or history of 2nd or 3rd degree atrioventricular block\n4. Concomitant use of CYP3A4 and CYP2D6 inhibitors\n5. Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure\n6. Amiodarone use within 3 months prior to enrollment\n7. Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation\n8. Expected life span \\< 1 year\n9. Creatinine clearance \\<30 mL/min\n10. Reversible cause of atrial fibrillation (ie. thyrotoxicosis)\n11. Unrevascularized coronary artery disease\n12. Canadian class IV angina\n13. Left ventricular ejection fraction \\<40%\n14. New York Heart Association Class III or IV symptoms\n15. Previous heart transplantation\n16. Planned heart transplantation or ventricular assist device\n17. Cardiac/thoracic surgery \\<6 months prior to enrollment\n18. Severe asthma or chronic obstructive pulmonary disease\n19. Breastfeeding'}, 'identificationModule': {'nctId': 'NCT02710669', 'briefTitle': 'New Formulations of Propafenone to Treat Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Comparison of (R) and (S) Propafenone for Prevention of Atrial Fibrillation Induction', 'orgStudyIdInfo': {'id': '151952'}, 'secondaryIdInfos': [{'id': '1R01HL124935-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL124935-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(R)-propafenone', 'description': 'Single intravenous dose of (R)-propafenone (2mg/kg) infused over 10 minutes', 'interventionNames': ['Drug: (R)-propafenone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(S)-Propafenone', 'description': 'Single intravenous dose of (S)-propafenone (2mg/kg) infused over 10 minutes', 'interventionNames': ['Drug: (S)-Propafenone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (normal saline) is infused over 10 minutes', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '(R)-propafenone', 'type': 'DRUG', 'armGroupLabels': ['(R)-propafenone']}, {'name': '(S)-Propafenone', 'type': 'DRUG', 'armGroupLabels': ['(S)-Propafenone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Bjorn Knollmann, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}, {'name': 'Ben Shoemaker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Pharmacology', 'investigatorFullName': 'Bjorn Knollmann', 'investigatorAffiliation': 'Vanderbilt University'}}}}