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| ID | Type | Description | Link |
|---|---|---|---|
| BWI202405 | Other Identifier | Biosense Webster, Inc. |
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The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator | Experimental | Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator | Device | Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure | PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis. | Within 7 days post index procedure |
| Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes | Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study. | Day 61-1095 post-index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Purcell | Contact | +1 949 230 3701 | EPurcel1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Biosense Webster, Inc. Clinical Trial | Biosense Webster, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Cardiovascular Research Group | Recruiting | Phoenix | Arizona | 85018 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Tucson Medical Center Pima Heart and Vascular |
| Recruiting |
| Tucson |
| Arizona |
| 85704 |
| United States |
| OC Memorial | Recruiting | Fountain Valley | California | 92708 | United States |
| San Diego Cardiac Center | Withdrawn | San Diego | California | 92123 | United States |
| Stanford Hospital and Clinics | Withdrawn | Stanford | California | 94305 | United States |
| Community Memorial Hospital | Recruiting | Ventura | California | 93003 | United States |
| Aurora Denver Cardiology Associates | Recruiting | Aurora | Colorado | 80012 | United States |
| Colorado Heart and Vascular PC | Withdrawn | Golden | Colorado | 80401 | United States |
| HCA Florida Mercy Hospital | Recruiting | Miami | Florida | 33133 | United States |
| Orlando Health Heart and Vascular Institute | Recruiting | Orlando | Florida | 32806 | United States |
| Deaconess Gateway Hospital | Withdrawn | Newburgh | Indiana | 47630 | United States |
| The Kansas City Heart Rhythm Institute | Recruiting | Overland Park | Kansas | 66211 | United States |
| Norton Heart and Vascular Institute | Withdrawn | Louisville | Kentucky | 40205 | United States |
| Trinity Health | Recruiting | Ypsilanti | Michigan | 48197 | United States |
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| Albert Einstein College Of Medicine - Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
| Springfield Medical Center | Recruiting | Springfield | Ohio | 45504 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Recruiting | Austin | Texas | 78705 | United States |
| Baylor Scott and White Research Institute | Recruiting | Fort Worth | Texas | 76104 | United States |
| Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano | Recruiting | Plano | Texas | 75093 | United States |
| Winchester Medical Center | Recruiting | Winchester | Virginia | 22601 | United States |
| Mercy Hospital | Recruiting | Janesville | Wisconsin | 53548 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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