The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
Study Details
Study Description
Brief Summary
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: FARAPULSE Pulsed Field Ablation System
|
Device: FARAPULSE Pulsed Field Ablation System
Ablation using the FARAPULSE Pulsed Field Ablation System
|
Active Comparator: Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
|
Device: RadioFrequency and Cryoballoon Ablation
Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
Outcome Measures
Primary Outcome Measures
- Composite Safety Endpoint;Proportion of Intent to Treat Subjects with one or more of the specified device or procedure related SAEs [7 days and 12 Months]
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs
- Treatment success [12 Months]
Acute procedural success and Chronic success
Secondary Outcome Measures
- PV Diameter change [3 months]
Change in pulmonary vein diameter
- Treatment Superiority [12 Months]
Treatment Success tested for superiority between the Pulsed Field and Thermal Groups.
Eligibility Criteria
Criteria
Key inclusion criteria: Patients are required to meet all the following inclusion criteria to participate in this study:
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Age 18-75
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Paroxysmal atrial fibrillation
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Anti-arrhythmic drug failed for efficacy or intolerance
Key exclusion criteria: Patients will be excluded from participating in this study if they meet any one of the following exclusion criteria:
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Atrial diameter greater than 5.5 cm
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Prior atrial ablation or surgery
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Left ventricular ejection fraction < 40%
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Implantable cardiac devices
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Heart surgery or stroke within 6 months of enrollment
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Renal impairment
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Body mass index greater than 40
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Grandview Medical Center | Birmingham | Alabama | United States | 35243 |
2 | The University of Alabama | Birmingham | Alabama | United States | 35294 |
3 | Banner University Medical Center | Phoenix | Arizona | United States | 85006 |
4 | Scripps Memorial Hospital La Jolla | La Jolla | California | United States | 92037 |
5 | California Pacific Medical Center | San Francisco | California | United States | 94109 |
6 | University of California San Francisco (UCSF) | San Francisco | California | United States | 94143 |
7 | Emory Saint Joseph's Hospital | Atlanta | Georgia | United States | 30322 |
8 | St Luke's Regional Medical Center | Boise | Idaho | United States | 83712 |
9 | Johns Hopkins | Baltimore | Maryland | United States | 21287 |
10 | Massachusetts General Hospital (MGH) | Boston | Massachusetts | United States | 02114 |
11 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
12 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
13 | Nebraska Methodist Health system, Inc | Omaha | Nebraska | United States | 68114 |
14 | Catholic Medical Center | Manchester | New Hampshire | United States | 03102 |
15 | NYU Langone Health_Heart Rhythm Center | New York | New York | United States | 10016 |
16 | Mount Sinai, Icahn School of Medicine | New York | New York | United States | 10029 |
17 | Northwell Health- Lenox Hill Hospital | New York | New York | United States | 10075 |
18 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
19 | Providence St Vincent Medical Center, Heart and Vascular Clinical Trials | Portland | Oregon | United States | 97225 |
20 | Doylestown Hospital | Doylestown | Pennsylvania | United States | 18901 |
21 | Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
22 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
23 | UPMC Pinnacle Health | Wormleysburg | Pennsylvania | United States | 17105 |
24 | Trident Medical Center | Charleston | South Carolina | United States | 29406 |
25 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
26 | Saint Thomas Health | Nashville | Tennessee | United States | 37205 |
27 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
28 | St Davids_Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705 |
29 | University of Virginia | Charlottesville | Virginia | United States | 22903 |
30 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
31 | MedStar Washington Hospital Center | Northwest | Washington | United States | 20010 |
Sponsors and Collaborators
- Farapulse, Inc.
Investigators
- Principal Investigator: Vivek Reddy, MD, Mt. Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS0934