The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation

NCT04612244 | Completed Results DMC FDA Device

• 1 other identifier: CS0934
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 34

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs

  Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs

  7 days and 12 Months

• Primary Effectiveness Endpoint

  Treatment Success: The primary effectiveness endpoint is Treatment Success in MITT Subjects, defined as: 1. Acute Procedural Success AND 2. Chronic Success, defined as freedom from: 1. At the Index / Rescheduled Index Procedure: Use of a non-randomized treatment modality for PVI 2. After the Blanking Period: i. Occurrence of any Detectable AF, AFL or AT (excluding CTI-dependent flutter confirmed by EP study) ii. Any cardioversion for AF, AFL or AT (excluding for CTI-dependent flutter) iii. Use of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL or AT c. At any time: i. Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter) ii. Use of amiodarone, except intra-procedurally to control an arrhythmia Endpoint status will be assessed through the Month 12 Assessment (Day 360 ± 30).

  12-Months

Secondary Outcomes (2)

• Change in PV Cross-sectional Area

  3 months

• Primary Effectiveness Treatment Success Tested for Superiority

  12 Months

Study Arms (2)

FARAPULSE Pulsed Field Ablation System

EXPERIMENTAL

Device: FARAPULSE Pulsed Field Ablation System

Force Sensing Radiofrequency Ablation and Cryoballoon Ablation

ACTIVE COMPARATOR

Device: RadioFrequency and Cryoballoon Ablation

Interventions

FARAPULSE Pulsed Field Ablation System DEVICE

Ablation using the FARAPULSE Pulsed Field Ablation System

FARAPULSE Pulsed Field Ablation System

RadioFrequency and Cryoballoon Ablation DEVICE

Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation

Force Sensing Radiofrequency Ablation and Cryoballoon Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with drug-resistant symptomatic PAF meeting all the following criteria:
• a. Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset.
• b. Frequency: i. Physician documentation of recurrent PAF (two or more episodes) within 6 months, AND
• ii. At least one (1) documented episode by a recording such as ECG, EM, Holter monitor or telemetry strip within 12 months of enrollment.
• c. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.
• Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
• Patient who are willing and capable of:
• Providing informed consent to undergo study procedures AND
• Participating in all examinations and follow-up visits and tests associated with this clinical study.

You may not qualify if:

• \. AF that is any of the following:
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• Persistent (both early and longstanding) by diagnosis or continuous duration \> 7 days
• Requires four (4) or more direct-current cardioversions in the preceding 12 months
• Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes
• \. Any of the following atrial conditions:
• Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
• Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
• Any prior atrial surgery
• Intra-atrial septal patch or interatrial shunt
• Atrial myxoma
• Current LA thrombus
• LA appendage closure, device or occlusion, past or anticipated
• Any PV abnormality, stenosis or stenting (common and middle PVs are admissible)
• \. At any time, one (1) or more of the following cardiovascular procedures, implants or conditions:

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (34)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

HonorHealth Scottsdale Shea

Scottsdale, Arizona, 85258, United States

Location

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

Location

California Pacific Medical Center

San Francisco, California, 94109, United States

Location

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

St Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Nebraska Methodist Health system, Inc

Omaha, Nebraska, 68114, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Hackensack University Medical Center/Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

NYU Langone Health_Heart Rhythm Center

New York, New York, 10016, United States

Location

Mount Sinai, Icahn School of Medicine

New York, New York, 10029, United States

Location

Northwell Health- Lenox Hill Hospital

New York, New York, 10075, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Providence St Vincent Medical Center, Heart and Vascular Clinical Trials

Portland, Oregon, 97225, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Pinnacle Health Cardiovascular Institute Inc.

Wormleysburg, Pennsylvania, 17105, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Saint Thomas Heart at Baptist Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

St Davids_Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

MedStar Washington Hospital Center

Northwest, Washington, 20010, United States

Location

Swedish Medical Center Heart & Vascular Research

Seattle, Washington, 98122, United States

Location

Related Publications (2)

• Reddy VY, Mansour M, Calkins H, d'Avila A, Chinitz L, Woods C, Gupta SK, Kim J, Eldadah ZA, Pickett RA, Winterfield J, Su WW, Waks JW, Schneider CW, Richards E, Albrecht EM, Sutton BS, Gerstenfeld EP; ADVENT Investigators. Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden. J Am Coll Cardiol. 2024 Jul 2;84(1):61-74. doi: 10.1016/j.jacc.2024.05.001. Epub 2024 May 18.

  PMID: 38864538 DERIVED

• Reddy VY, Gerstenfeld EP, Natale A, Whang W, Cuoco FA, Patel C, Mountantonakis SE, Gibson DN, Harding JD, Ellis CR, Ellenbogen KA, DeLurgio DB, Osorio J, Achyutha AB, Schneider CW, Mugglin AS, Albrecht EM, Stein KM, Lehmann JW, Mansour M; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671. doi: 10.1056/NEJMoa2307291. Epub 2023 Aug 27.

  PMID: 37634148 DERIVED

Related Links

• Publication of ADVENT results (PubMed)

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Allison Anderson
• Organization: BSC

allison.anderson@bsci.com

651-582-5077

Study Officials

• Vivek Reddy, MD

  Mt. Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: March 1, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)