Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-03-13 @ 2:03 PM
Study NCT ID:
NCT03943693
Status:
TERMINATED
Last Update Posted:
2021-10-29
First Post:
2019-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Versus Single Shock for Cardioversion of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardioversion to sinus rhythm', 'timeFrame': 'Immediately following cardioversion', 'description': 'Successful termination of atrial fibrillation after initial DCCV. Successful = cardioversion = immediate termination of atrial fibrillation'}], 'secondaryOutcomes': [{'measure': 'Maintenance of normal sinus rhythm at one hour post cardioversion', 'timeFrame': 'Within 24 hours'}, {'measure': 'Presence of symptomatic skin burn', 'timeFrame': 'Immediately following cardioversion', 'description': 'Symptoms rated on a scale 1-10'}, {'measure': 'Thromboembolic complications', 'timeFrame': 'Within 24 hours'}, {'measure': 'Ventricular arrhythmias requiring additional shock therapy', 'timeFrame': 'Immediately following cardioversion'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cardioversion'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '10588220', 'type': 'BACKGROUND', 'citation': 'Saliba W, Juratli N, Chung MK, Niebauer MJ, Erdogan O, Trohman R, Wilkoff BL, Augostini R, Mowrey KA, Nadzam GR, Tchou PJ. Higher energy synchronized external direct current cardioversion for refractory atrial fibrillation. J Am Coll Cardiol. 1999 Dec;34(7):2031-4. doi: 10.1016/s0735-1097(99)00463-5.'}, {'pmid': '24345399', 'type': 'RESULT', 'citation': 'Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.'}, {'pmid': '17493088', 'type': 'RESULT', 'citation': 'Boriani G, Diemberger I, Biffi M, Domenichini G, Martignani C, Valzania C, Branzi A. Electrical cardioversion for persistent atrial fibrillation or atrial flutter in clinical practice: predictors of long-term outcome. Int J Clin Pract. 2007 May;61(5):748-56. doi: 10.1111/j.1742-1241.2007.01298.x.'}, {'pmid': '16159494', 'type': 'RESULT', 'citation': 'Larsen MT, Lyngborg K, Pedersen F, Corell P. [Predictive factors of maintenance of sinus rhythm after direct current (DC) cardioversion of atrial fibrillation/atrial flutter]. Ugeskr Laeger. 2005 Sep 5;167(36):3408-12. Danish.'}, {'pmid': '22982132', 'type': 'RESULT', 'citation': 'Vinolas X, Freire F, Romero-Menor C, Alegret JM. [Predictors of reversion to sinus rhythm previous to electrical cardioversion in patients with persistent atrial fibrillation treated with anti-arrhythmic drugs]. Med Clin (Barc). 2013 Apr 20;140(8):351-5. doi: 10.1016/j.medcli.2012.02.026. Epub 2012 Sep 14. Spanish.'}, {'pmid': '11584453', 'type': 'RESULT', 'citation': 'Marrouche NF, Bardy GH, Frielitz HJ, Gunther J, Brachmann J. Quadruple pads approach for external cardioversion of atrial fibrillation. Pacing Clin Electrophysiol. 2001 Sep;24(9 Pt 1):1321-4. doi: 10.1046/j.1460-9592.2001.01321.x.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to investigate the immediate success rate (rate of termination of atrial fibrillation) of dual shock cardioversion compared with standard single shock cardioversion in patients with baseline characteristics adversely influencing successful cardioversion. Baseline characteristics known to reduce the success rate of single shock cardioversion include: increased body mass index (BMI), chronic obstructive pulmonary disease, sleep apnea, enlarged left atrium, longer duration of atrial fibrillation and use of amiodarone.', 'detailedDescription': 'Patient Enrollment Patient enrollment will be open enrollment to inpatient/outpatients who meet the inclusion/exclusion criteria listed above. This is a double-blinded study with randomization to dual shock or standard single shock synchronized cardioversion for patients requiring cardioversion for atrial fibrillation. Randomization will be performed using a standard computer-based randomization system.\n\nCardioversion will be performed with Zoll R series Defibrillator, which was approved by the FDA in 2017 for use as a defibrillator, with a 510K approval for use in cardioversion of atrial arrhythmias. After obtaining consent, before sedation is administered, all patients will have 2 pads placed in the antero-posterior pad position on the left chest (guideline recommended position for cardioversion of atrial fibrillation) and an additional 2 pads placed in the standard Ventricular Tachycardia/Advanced Cardiac Life Support positions, where the anterior pad is centered over the right infraclavicular space and the apical pad is placed over the left axilla . All patients will be sedated using propofol administered by anesthesiology or a combination of fentanyl and midazolam administered by cardiology staff.\n\nPatients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only. A repeat attempt will be made using the same approach if the initial shock fails. If the second attempt fails, the single shock approach will be considered to have failed. Patients will be crossed over to dual shock therapy while under the same sedation episode. For cross-over patients, two near-simultaneous 200-Joule shocks will be delivered through the two sets of pads already in position. If this fails further treatment will be determined by the primary team/attending cardiologist.\n\nPatients randomized to the dual shock group will have two near-simultaneous 200-Joule shocks delivered through the two sets of pads (antero-posterior position and right infraclavicular-axillary position). The first of these shocks will be synchronized. If the first attempt with this approach fails to terminate atrial fibrillation a second attempt will be made using the same approach. If the second attempt fails the dual shock approach will be considered to have failed and further treatment will be determined by the primary team/attending cardiologist.\n\nPrimary Endpoint - Successful termination of atrial fibrillation after initial Direct Current Ccardioversion (DCCV). Successful cardioversion = immediate termination of atrial fibrillation with electrocardiographic (ECG) evidence of atrial fibrillation (AF) termination. The physician deciding whether AF was successfully terminated will be blinded to whether the shock was with single or dual shocks. - Partial success will be considered if atrial fibrillation is terminated by the second attempt using the same approach. Secondary Endpoints - Maintenance of normal sinus rhythm at one hour post cardioversion - Presence of symptomatic skin burn (symptoms rated on a scale of 1-10) - Thromboembolic complications - Ventricular Arrhythmias requiring additional shock therapy Documentation of Anticoagulation All patients need to have established therapeutic anticoagulation. Either 1) Therapeutic warfarin (with International normalized ratio (INR) \\>2) or therapeutic doses of apixaban, dabigatran, rivaroxaban or edoxaban for at least 3 consecutive weeks before and with plans to continue 4 weeks after cardioversion. 2) Therapeutic anticoagulation with intravenous heparin or therapeutic subcutaneous enoxaparin or non-vitamin K oral anticoagulant if atrial fibrillation episode is known to be of recent onset (\\<48 hours), with anticoagulation to continue for at least one week post cardioversion. 3) Sub-therapeutic or no anticoagulation preceding cardioversion, but transesophageal echocardiogram (TEE) confirming absence of intra-cardiac thrombus. Therapeutic anticoagulation should be administered just prior to cardioversion and planned to continue for at least 4 weeks post cardioversion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient or inpatients with atrial fibrillation sent for elective direct current cardioversion (DCCV) with at least 1 of the following risk factors will be included:\n\n * BMI \\>30\n * History of Chronic Obstructive Pulmonary Disease/emphysema/asthma\n * Significant Valvular heart disease (at least moderate regurgitation/stenosis)\n * History of Heart Failure with preserved Ejection Fraction/Heart Failure with reduced Ejection Fraction\n * Cardiomyopathy with ejection fraction \\<40%\n * Left atrium anterior-posterio (AP) dimension \\>4.5cm\n * Presence of Left ventricular hypertrophy (≥1.1cm septal/posterior wall M-mode) on transthoracic echocardiogram\n * History of sleep apnea\n\nExclusion Criteria:\n\n* Consent not obtained\n* \\<18 y.o.\n* \\>80 y.o.\n* Not adequately anti-coagulated\n* Patient hemodynamically unstable and DCCV required as an emergent procedure\n* Prisoners or pregnant patients'}, 'identificationModule': {'nctId': 'NCT03943693', 'briefTitle': 'Dual Versus Single Shock for Cardioversion of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Dual Shock Versus Single Shock Synchronized External Direct Current Cardioversion for Atrial Fibrillation - A Double-blinded Randomized Trial', 'orgStudyIdInfo': {'id': '10276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single Shock Group', 'description': 'Patients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only.', 'interventionNames': ['Device: Single shock']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double Shock Group', 'description': 'Patients randomized to the dual shock group will have two near-simultaneous 200-Joule shocks delivered through the two sets of pads (antero-posterior position and right infraclavicular-axillary position). The first of these shocks will be synchronized.', 'interventionNames': ['Device: Double shock']}], 'interventions': [{'name': 'Double shock', 'type': 'DEVICE', 'description': 'Patients randomized to the dual shock group will have two near-simultaneous 200-Joule shocks delivered through the two sets of pads (antero-posterior position and right infraclavicular-axillary position). The first of these shocks will be synchronized. If the first attempt with this approach fails to terminate atrial fibrillation a second attempt will be made using the same approach. If the second attempt fails the dual shock approach will be considered to have failed and further treatment will be determined by the primary team/attending cardiologist.', 'armGroupLabels': ['Double Shock Group']}, {'name': 'Single shock', 'type': 'DEVICE', 'description': 'Patients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only. A repeat attempt will be made using the same approach if the initial shock fails. If the second attempt fails, the single shock approach will be considered to have failed. Patients will be crossed over to dual shock therapy while under the same sedation episode. For cross-over patients, two near-simultaneous 200-Joule shocks will be delivered through the two sets of pads already in position. If this fails further treatment will be determined by the primary team/attending cardiologist.', 'armGroupLabels': ['Single Shock Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73105', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Deborah Lockwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}