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Persistent Atrial FibrillationPhase 4PROSPECTNCT06765356

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

A Phase 4 study testing Farapulse Catheter System and Low-dose Colchicine in people with Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Vivek Reddy at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Farapulse Catheter System and Low-dose Colchicine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
9 sitesUnited States
Study dates
15 Apr 2025to 30 Mar 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • UPMC Pinnacle Hospitals

    Harrisburg, Pennsylvania, 17101

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

  • Naples Comprehensive Health

    Naples, Florida, 34102

  • Mount Sinai Morningside

    New York, New York, 10025

  • The Mount Sinai Hospital

    New York, New York, 10029

  • Trident Medical Center

    North Charleston, South Carolina, 29406

  • Cardiology Associates Medical Group

    Ventura, California, 93003

  • Sentara Health Research Center

    Virginia Beach, Virginia, 23455

Other trials in United States

About this study

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

Read the detailed description

By virtue of its efficiency, safety profile, and potential for improved efficacy, there is tremendous excitement about the role of pulsed field ablation (PFA) to treat atrial fibrillation. Indeed, multiple FDA IDE clinical trials on PFA have been, or are being, conducted to treat AF. However, most FDA pivotal trials studying PFA enroll very selected populations and have highly focused inclusion/exclusion criteria and, typically only paroxysmal or persistent AF patients with limited upper age criteria are included, failure of Class I/III AADs is often required, and other disease states that may particularly benefit from PFA (e.g., PFA might be particularly effective in treating HCM pts with their thickened atrial tissue).

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.

Being tested
Farapulse Catheter System, Low-dose Colchicine
Keywords
Atrial Fibrillation, A-Fib, Treatment of Atrial Fibrillation, A-Fib Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Farapulse Catheter SystemDevice

    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 ColchicineDrug

    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.

Study groups in NCT06765356
Study groupRoleWhat they receive
Patients with Atrial FibrillationExperimentalAll patients will receive treatment using the Farapulse catheter system (Farawave catheter used in combination with the Farastar generator).
Receives: Device: Farapulse Catheter System; Drug: Low-dose Colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: at the end of the procedure (approximately 60 minutes)

Secondary outcomes (16)

  1. Number of Chronic Single-Procedure Success

    Chronic Single-Procedure Success is defined as freedom from all of the following:

    • Any Detectable AF, AFL or AT;
    • Any re-ablation for AF, AFL or AT;
    • Any cardioversion for AF, AFL or AT;
    • Any use of a non-Failed Class I/III AAD or Amiodarone

    Where "Detectable AF, AFL or AT" refers to either of the following as recorded by the ICM:

    • Symptomatic (patient-initiated) recording containing ≥ 30 seconds of continuous AF or AT/AFL
    • Automatically-detected AF or AT/AFL episodes measured at ≥1 hour in duration (asymptomatic)

    Measured: up to 12 months post procedure

  2. Number of Participant to Achieve Linear Lesion Bidirectional Block

    Ability to achieve linear lesion bidirectional block using the Farawave catheter alone; for this endpoint, all linear lesions (CTI and Mitral Isthmus) will be aggregated. This will be ascertained acutely after either a 20 min waiting period or despite pharmacologic stress (eg., IV adenosine or IV isoproterenol).

    Measured: at the end of the procedure (approximately 60 minutes)

  3. Incidence of Primary Adverse Events (PAEs)

    Incidence of Primary Adverse Events (PAEs) (within 7 days of the initial procedure). PAEs include the following AEs:

    • Atrio-Esophageal Fistula
    • Phrenic Nerve Paralysis
    • Cardiac Tamponade/perforation
    • Pulmonary Vein Stenosis
    • Death
    • Stroke/CVA
    • Major Vascular Access
    • Complication/Bleeding
    • Thromboembolism
    • Myocardial Infarction TIA
    • Device or procedure related death
    • pulmonary vein stenosis and atrio-esophageal fistula that occur greater than one week (7 days) post-procedure are also considered and analyzed as primary AEs.

    Measured: within 7 days of procedure

  4. Number of patients who developed pericarditis

    Number of patients who developed clinical pericarditis within 2 weeks following ablation. This will be ascertained by comprehensive chart review plus at the routine post-ablation follow-up phone visit at 7 days

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

  5. Incidence of Serious Adverse Device Effects (SADEs)

    Incidence of Serious Adverse Device Effects (SADEs)

    Measured: end of study at 12 months

  6. Incidence of Gastrointestinal symptoms

    Incidence of Gastrointestinal symptoms (necessitating cessation of colchicine therapy) for participants in the substudy

    Measured: end of study at 12 months

  7. Freedom from detectable AF, AFL or AT off AADs

    Freedom from detectable AF, AFL or AT off AADs, defining detectable AF, AFL or AT as Freedom from detectable AF, AFL or AT

    Measured: end of study 12 months

  8. Number of patients who achieve CT isthmus block

    Number of patients achieving CT isthmus block using the Farawave catheter alone will be recorded.

    Measured: end of study 12 months

  9. Freedom from persistent AF at 12 months off AADs

    Freedom from persistent AF at 12 months off AADs

    Measured: end of study 12 months

  10. Freedom from symptomatic AT/AF/AFL recurrence

    Freedom from symptomatic AT/AF/AFL recurrence

    Measured: end of study 12 months

  11. Change in Blood interleukin-6

    Inflammation is common among those with type 2 diabetes. Inflammatory markers (chemicals in the body that lead to inflammation), such as interleukin-6 (Il-6) have been found to be increased in those with type 2 diabetes

    For participants in substudy.

    Measured: 5 days pre-PFA and 48-72 hours post-PFA

  12. Change in C-reactive protein (CRP)

    C-reactive protein (CRP) is produced by the liver. The CRP test is a general test to check for inflammation in the body. It is not a specific test. This means it can reveal that inflammation somewhere in the body, but it cannot pinpoint the exact location or reason. The CRP test is often done with the ESR (erythrocyte or sedimentation rate) test which also looks for inflammation.

    For participants in substudy.

    Measured: 5 days pre-PFA and 48-72 hours post-PFA

  13. Changes in Tumor Necrosis Factor (TNF)-α

    Many people take medicines to reduce the immune system's abnormal response. These are called immunosuppressive medicines. Targeted drugs such as tumor necrosis factor (TNF) blockers can be used for some diseases.

    For participants in substudy.

    Measured: 5 days pre-PFA and 48-72 hours post-PFA

  14. Changes in Erythrocyte Sedimentation Rate (ESR)

    Erythrocyte sedimentation rate (ESR) is also commonly called a sed rate. It is a test that indirectly measures the level of certain proteins in the blood. This measurement correlates with the amount of inflammation in the body.

    For participants in substudy.

    Measured: 5 days pre-PFA and 48-72 hours post-PFA

  15. Brain natriuretic peptide (BNP) levels

    Brain natriuretic peptide (BNP) test is a blood test that measures levels of a protein called BNP that is made by the heart and blood vessels. BNP levels go up when the heart cannot pump the way it should. A result greater than 100 pg/mL is abnormal. The higher the number, the more likely heart failure is present and the more severe it is.

    For participants in substudy.

    Measured: 5 days pre-PFA and 48-72 hours post-PFA

  16. Change in durability of lesion sets in any patient that undergoes a second procedure

    Change in Durability of lesion sets in any patient that undergoes a second procedure (block across attempted lines, absence of electrograms in targeted substrate). Observe if the block(s) achieved at the targeted sites from the index procedure have persisted

    Measured: baseline (index procedure) and end of study 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start15 Apr 2025
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06765356
Sponsor's protocol ID
BRANY 24-02-283
Acronym
PROSPECT
Status last verified
Apr 2026
First submitted
3 Jan 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 31085321

  • 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.

    PubMed 32383391

  • 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.

    PubMed 37634148

  • 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.

    PubMed 33933412

  • 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.

    PubMed 37199171

  • 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.

    PubMed 37379528

  • 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.

    PubMed 28506916

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Farapulse Catheter System and Low-dose Colchicine in people with Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Vivek Reddy at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Acute Procedural Success (time frame: at the end of the procedure (approximately 60 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06765356, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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