Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-11 @ 9:08 PM
Study NCT ID:
NCT05881733
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2023-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.c.yap@erasmusmc.nl', 'phone': '+31650031551', 'title': 'Dr. Sing-Chien Yap', 'organization': 'Erasmus MC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Study population', 'description': 'This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.\n\nPOLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Esophageal perforation', 'notes': 'Esophageal perforation requiring major surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study population', 'description': 'This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.\n\nPOLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '13.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Interprocedural (directly after cryoablation)', 'description': 'Low-voltage areas will be quantified using a bipolar voltage \\<0.3 mV. The sum of the posterior ablated areas of all pulmonary veins is expressed as a percentage of the total left atrial posterior wall.', 'unitOfMeasure': 'percentage of posterior wall', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Pulmonary_veins', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study population', 'description': 'This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.\n\nPOLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Interprocedural (before cryoablation)', 'description': 'A grade 4 occlusion is defined as complete contrast stasis. Cine acquisitions of contrast vein occlusions was analyzed by two experienced observers.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pulmonary_veins', 'denomUnitsSelected': 'Pulmonary_veins', 'populationDescription': 'There were 4 pulmonary veins per participant. Thus, in 20 participants there were 80 pulmonary veins. We determined the percentage of pulmonary veins which had a grade 4 occlusion with the 31 mm balloon size of the POLARx FIT catheter. In 69 of 80 pulmonary veins (86%) a grade 4 occlusion with the 31 mm balloon size could be achieved.'}, {'type': 'SECONDARY', 'title': 'Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Pulmonary_veins', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study population', 'description': 'This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.\n\nPOLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Interprocedural (directly after cryoablation)', 'description': 'Pulmonary vein isolation will be determined using conventional criteria: entry- and exit-block as assessed with the circular mapping catheter (POLARMAP).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pulmonary_veins', 'denomUnitsSelected': 'Pulmonary_veins', 'populationDescription': 'There were 4 pulmonary veins per participant. Thus, in 20 participants there were 80 pulmonary veins. We determined the percentage of pulmonary veins which were isolated after 1 cryoapplication with the 31 mm balloon size of the POLARx FIT catheter. 63 of 80 pulmonary veins (79%) were isolated after 1 cryoapplication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study population', 'description': 'This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.\n\nPOLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Population', 'description': 'This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.\n\nPOLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.7', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-16', 'size': 7028052, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-04T10:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single-arm, single-center, study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2023-05-21', 'resultsFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-15', 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT', 'timeFrame': 'Interprocedural (directly after cryoablation)', 'description': 'Low-voltage areas will be quantified using a bipolar voltage \\<0.3 mV. The sum of the posterior ablated areas of all pulmonary veins is expressed as a percentage of the total left atrial posterior wall.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT', 'timeFrame': 'Interprocedural (before cryoablation)', 'description': 'A grade 4 occlusion is defined as complete contrast stasis. Cine acquisitions of contrast vein occlusions was analyzed by two experienced observers.'}, {'measure': 'Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter', 'timeFrame': 'Interprocedural (directly after cryoablation)', 'description': 'Pulmonary vein isolation will be determined using conventional criteria: entry- and exit-block as assessed with the circular mapping catheter (POLARMAP).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryoballoon', 'Atrial fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The investigators will prospectively evaluate the extent of antral lesion created by the 31 mm balloon size of a novel cryoballoon catheter (POLARx FIT). In 20 patients with paroxysmal atrial fibrillation, the investigators will perform pre- and post-ablation high-definition 3D maps to quantify the extent of lesion created by the 31 mm POLARx FIT cryoballoon.', 'detailedDescription': 'Rationale: The next generation POLARx cryoablation balloon (CB) catheter will have the option of to deliver cryotherapy with the current balloon size of 28 mm or a new, larger 31 mm size by changing the inner balloon pressure (POLARx FIT, Boston Scientific). Currently, there is no data on the extension of left atrial (LA) lesion formation with the 31 mm balloon size of the POLARx FIT cryoablation balloon catheter. The hypothesis is that a larger CB size results in a wide antral circumferential lesion.\n\nObjective: The primary objective is to evaluate the antral lesion size using ultrahigh-density (UHDx) mapping pre- and post-cryoablation with the 31 mm balloon size CB. Secondary objectives are the proportion of pulmonary veins (PVs) where a 31 mm CB could be positioned to achieve a grade 4 occlusion and the single shot success rate with the 31 mm balloon size CB.\n\nStudy design: Single-center, single-arm, prospective study with pre- and post-PVI UHDx mapping.\n\nStudy population: Twenty adult patients with paroxysmal AF who are scheduled to undergo pulmonary vein isolation (PVI) with a CB.\n\nIntervention: Patients will undergo pre- and post-ablation UHDx mapping (Orion catheter and Rhythmia 3D-mapping system, Boston Scientific) during the index procedure.\n\nMain study parameters/endpoints: The primary endpoint is the extent of the antral lesion size. Secondary endpoints are the proportion of PVs with grade 4 occlusion with the 31 mm balloon size CB, the single shot success rate of the 31 mm balloon size CB, difference in rate of achieving grade 4 occlusion in comparison to the standard (28 mm) size.\n\nNature and extent of the burden and risks associated with participation, benefit, and group relatedness: A UHDx mapping will be acquired before and after complete PVI. The procedures will be performed under deep sedation, which is standard practice for CB procedures in our institution. The risk of additional mapping is limited. LA mapping is a standard diagnostic method for patients undergoing PVI with radiofrequency ("standard-of-care"). In the current study, UHDx mapping will now be used in patients undergoing PVI with CB. The most important complication of additional intracardiac mapping is cardiac tamponade, but this risk is low (\\<0.5%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of symptomatic paroxysmal AF\n2. Subjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF\n3. Subjects who are willing and capable of providing informed consent\n4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation\n5. Subjects whose age is 18 years or above\n\nExclusion Criteria:\n\n1. Any known contraindication to an AF ablation or anticoagulation\n2. History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia\n3. AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause\n4. Significant structural heart disease as evidenced by:\n\n 1. Left ventricular ejection fraction \\<45% based on most recent transthoracic echocardiogram (TTE) performed \\<6 months prior to enrollment\n 2. LA diameter \\>55 mm based on most recent TTE performed \\<6 months prior to enrollment\n 3. Previous cardiac surgery\n 4. Previous cardiac valvular surgical or percutaneous procedure\n 5. Interatrial baffle, closure device, patch, or occluder\n 6. Unstable angina or ongoing myocardial ischemia\n 7. Moderate or severe valvular heart disease on most recent TTE performed \\<6 months prior to enrolment\n 8. Congenital heart disease\n 9. Left atrial thrombus\n5. History of blood clotting or bleeding disease\n6. Stroke or transient ischemic attack \\<3 months prior to enrollment\n7. Active systemic infection\n8. Common ostium PV \\>24 mm defined by CT-scan\n9. Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study\n10. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study'}, 'identificationModule': {'nctId': 'NCT05881733', 'acronym': 'BETTER-FIT', 'briefTitle': 'Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT', 'orgStudyIdInfo': {'id': 'MEC-2023-0325'}, 'secondaryIdInfos': [{'id': 'NL84423.078.23', 'type': 'REGISTRY', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study population', 'description': 'This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.', 'interventionNames': ['Device: POLARx FIT cryoballoon']}], 'interventions': [{'name': 'POLARx FIT cryoballoon', 'type': 'DEVICE', 'description': 'Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.', 'armGroupLabels': ['Study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Sing-Chien Yap, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist-electrophysiologist', 'investigatorFullName': 'Sing-Chien Yap, MD, PhD', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}