Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
NCT ID: NCT06765356
Last Updated: 2025-11-26
Study Results
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Basic Information
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RECRUITING
PHASE4
275 participants
INTERVENTIONAL
2025-04-15
2027-03-30
Brief Summary
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Detailed Description
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In observational European studies of the FARAPULSE catheter system, the technology has proved quite safe and effective in treating most patients with AF. It is a highly efficient ablation system, and can be employed with only deep sedation, and without the need for endotracheal intubation. In addition to the FARAWAVE catheter performing PV isolation and ablation of the posterior left atrium, in the MANIFEST-PF post-approval study of EU experience, the FARAWAVE catheter has also been shown able to create other relevant ablation lesions such as cavo-tricuspid isthmus ablation for typical atrial flutter, or a mitral isthmus line for mitral isthmus flutter.
The FARAWAVE multielectrode pentaspline PFA catheter is the study device. It can be deployed in a basket or flower configuration: 1) Both configurations can be used to isolate PVs, 2) The flower configuration can be used to ablate the posterior wall, and 3) Flower configuration for creation of CTI or Mitral Isthmus Lines.
The ablation procedure will typically follow the below sequence:
* Pulmonary Vein Isolation (PVI) to be achieved in all patients with atrial fibrillation
* Posterior wall Ablation: will be used in all persistent/LS-Per AF patients, and as per operator discretion, some paroxysmal AF patients
* Additional ablation lesion sets are per investigators' discretion:
* Cavo-tricuspid isthmus line
* Mitral Isthmus Line
* Regional fractionation clusters (allowed but not encouraged)
* Any micro-/macro-reentrant atrial tachycardia's
* When PFA is performed next to a coronary artery (eg, CTI or mitral isthmus lines), a nitroglycerin pretreatment protocol will be employed as per study protocol.
* As part of the ablation procedure, any safety assessments that are considered important (e.g., EGD, coronary angiography, etc.) may be performed as per the investigators' discretion; these data will also be collected.
* For a lesion set that cannot be performed using the FARAPULSE catheter technology, a conventional FDA-approved ablation catheter may be used to complete the procedure as per whatever is optimal for the patient outcome
This study is a prospective, multi-center, non-randomized, investigator-initiated IDE clinical study to determine the safety and efficacy of the recently FDA-approved FARAPULSE system to treat the "usual" patients presenting in clinical practice for catheter ablation of AF. (An IDE is required because the approval for the FARAPULSE system: i) only includes paroxysmal AF patients, and ii) doesn't include the technology's use for linear lesions such as the cavo-tricuspid isthmus line. Participants will be followed for 12-months post-procedure.
There is an optional randomized sub-study looking at the utility of peri-procedural low-dose colchicine in attenuating PFA-related pericardial inflammation and its negative effects (symptoms and atrial arrhythmias). Participants will start low-dose colchicine 5 days prior to PFA procedure and continue up to 3 weeks post-PFA treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with Atrial Fibrillation
All patients will receive treatment using the Farapulse catheter system (Farawave catheter used in combination with the Farastar generator).
Farapulse Catheter System
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.
Low-dose Colchicine
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.
Interventions
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Farapulse Catheter System
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.
Low-dose Colchicine
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Vivek Reddy
OTHER
Responsible Party
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Vivek Reddy
Director, Cardiac Arrhythmia Service
Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
The Mount Sinai Hospital, Icahn School of Medicine
Locations
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Arrhythmia Research Group
Jonesboro, Arkansas, United States
Naples Comprehensive Health
Naples, Florida, United States
The Mount Sinai Hospital
New York, New York, United States
UPMC Pinnacle Hospitals
Harrisburg, Pennsylvania, United States
Trident Medical Center
North Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BRANY 24-02-283
Identifier Type: -
Identifier Source: org_study_id
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