Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

NCT06765356 | Active Not Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: BRANY 24-02-283
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

Conditions

Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Long-standing Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation; A-Fib; Treatment of Atrial Fibrillation; A-Fib Ablation

Outcome Measures

Primary Outcomes (1)

• Number of Acute Procedural Success

  Acute Procedural Success is defined as confirmation of entrance block in all targeted PVs, and acute block of all linear lesions that are attempted (eg, CTI or mitral isthmus line). (The use of a non-study catheter for PVI will be considered an effectiveness failure; however, use of a non-study catheter for ablation unrelated to PVI will be noted, but not considered a treatment failure)

  at the end of the procedure (approximately 60 minutes)

Secondary Outcomes (16)

• Number of Chronic Single-Procedure Success

  up to 12 months post procedure

• Number of Participant to Achieve Linear Lesion Bidirectional Block

  at the end of the procedure (approximately 60 minutes)

• Incidence of Primary Adverse Events (PAEs)

  within 7 days of procedure

• Number of patients who developed pericarditis

  within 2 weeks from procedure, and at 7 days follow-up visit

• Incidence of Serious Adverse Device Effects (SADEs)

  end of study at 12 months

Study Arms (1)

Patients with Atrial Fibrillation

EXPERIMENTAL

All patients will receive treatment using the Farapulse catheter system (Farawave catheter used in combination with the Farastar generator).

Device: Farapulse Catheter System; Drug: Low-dose Colchicine

Interventions

Farapulse Catheter System DEVICE

The FARAWAVE PFA Catheter is a sterile, single use, over-the-wire, non-deflectable device that is used with the FARASTAR Catheter Connection Cable and FARASTAR Generator to enable delivery of Pulsed Field Ablation energy for irreversible electroporation. The FARAWAVE PFA Catheter has five (5) variably deployable splines. The five splines are undeployed during insertion and removal and during use can deploy continuously from an undeployed state through a partially deployed ("basket-shaped") configuration to a fully deployed ("flower-shaped") configuration with five petals.

Patients with Atrial Fibrillation

Low-dose Colchicine DRUG

For participants in the colchicine sub-study, 0.3 mg BID Colchicine. Colchicine will be prescribed to the patient starting 5 days prior to ablation. Patient will continue the colchicine for 3 weeks post-ablation.

Patients with Atrial Fibrillation

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Diagnosed with atrial fibrillation with or without concomitant atrial flutter by ECG at some point in the past, and by any criteria (ECG or clear symptoms within the past year)
• Previous catheter ablation for other arrhythmias (including left-sided ablation, but not for AF) is allowed
• Planned for a clinically-indicated catheter ablation procedure for managing paroxysmal or persistent atrial fibrillation in accordance with the following recommendations in the ACC/AHA/ACCP/HRS guidelines
• In patients with symptomatic AF in whom antiarrhythmic drugs have been ineffective, contraindicated, not tolerated or not preferred, and continued rhythm control is desired, catheter ablation is useful to improve symptoms.(Class 1)
• In selected patients (generally younger with few comorbidities) with symptomatic paroxysmal AF in whom rhythm control is desired, catheter ablation is useful as first-line therapy to improve symptoms and reduce progression to persistent AF. (Class 1)
• In patients (other than younger with few comorbidities) with symptomatic paroxysmal or persistent AF who are being managed with a rhythm-control strategy, catheter ablation as first-line therapy can be useful to improve symptoms. (Class 2a)
• In selected patients with asymptomatic or minimally symptomatic AF, catheter ablation may be useful for reducing progression of AF and its associated complications. (Class 2b)
• In patients who present with a new diagnosis of HFrEF and AF, arrhythmia-induced cardiomyopathy should be suspected, and an early and aggressive approach to AF rhythm control is recommended. (Class 1)
• In appropriate patients with AF and HFrEF who are on GDMT, and with reasonable expectation of procedural benefit, catheter ablation is beneficial to improve symptoms, QOL, ventricular function, and cardiovascular outcomes. (Class 1)
• In appropriate patients with symptomatic AF and HFpEF with reasonable expectation of benefit, catheter ablation can be useful to improve symptoms and improve QOL. (Class 2a)
• In athletes who develop AF, catheter ablation with PVI is a reasonable strategy for rhythm control because of its effectiveness and low risk of detrimental effect on exercise capacity. (Class 2a)
• Have in place or have plans for implantation of a loop recorder, pacemaker or cardiac defibrillator capable of recording atrial rhythm (e.g. dual chamber) (ideally, this implantable device would be present for at least 4 weeks pre-PFA)
• Able and willing to provide written consent and comply with all testing and follow-up requirements

You may not qualify if:

• Documented "active" left atrial thrombus (patients may later undergo the procedure if this is no longer present, eg, with anticoagulation treatment)
• Reversible cause of AF (e.g., post-operative, thyroid disorder, etc.)
• Conditions that make an AF ablation procedure unlikely to be successful (e.g., advanced infiltrative cardiomyopathies like amyloid, severe mitral stenosis or regurgitation, and cor pulmonale)
• PCI/STEMI within the prior 1 month
• Active systemic infection or sepsis
• Contraindication to all anticoagulation
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude an ablation procedure
• Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
• Life expectancy or other disease processes likely to limit survival to less than 12 months
• Currently, enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.

Sponsors & Collaborators

• Vivek Reddy: lead
• Boston Scientific Corporation: collaborator

Study Sites (9)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Naples Comprehensive Health

Naples, Florida, 34102, United States

Location

Mount Sinai Morningside

New York, New York, 10025, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

UPMC Pinnacle Hospitals

Harrisburg, Pennsylvania, 17101, United States

Location

Trident Medical Center

North Charleston, South Carolina, 29406, United States

Location

Sentara Health Research Center

Virginia Beach, Virginia, 23455, United States

Location

Related Publications (7)

• Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

  PMID: 31085321 BACKGROUND

• Reddy VY, Anter E, Rackauskas G, Peichl P, Koruth JS, Petru J, Funasako M, Minami K, Natale A, Jais P, Nakagawa H, Marinskis G, Aidietis A, Kautzner J, Neuzil P. Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008718. doi: 10.1161/CIRCEP.120.008718. Epub 2020 May 8.

  PMID: 32383391 BACKGROUND

• 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 BACKGROUND

• Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

  PMID: 33933412 BACKGROUND

• Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Futing A, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adelino R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, Rahe G, Reddy VY. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulation. 2023 Jul 4;148(1):35-46. doi: 10.1161/CIRCULATIONAHA.123.064959. Epub 2023 May 18.

  PMID: 37199171 BACKGROUND

• Schmidt B, Bordignon S, Neven K, Reichlin T, Blaauw Y, Hansen J, Adelino R, Ouss A, Futing A, Roten L, Mulder BA, Ruwald MH, Mene R, van der Voort P, Reinsch N, Kueffer T, Boveda S, Albrecht EM, Schneider CW, Chun KRJ. EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry. Europace. 2023 Jul 4;25(7):euad185. doi: 10.1093/europace/euad185.

  PMID: 37379528 BACKGROUND

• Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

  PMID: 28506916 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Vivek Reddy, MD

  The Mount Sinai Hospital, Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cardiac Arrhythmia Service

Model Details: Non-randomized, interventional clinical study to determine the safety and efficacy in using Pulse Field Ablation with the FARAPULSE Catheter System in the treatment of persistent or paroxysmal atrial fibrillation. All patients will receive the intervention.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)