Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

NCT ID: NCT04198701

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2022-11-28

Brief Summary

The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilot

First group of patients enrolled in the study.

Group Type: EXPERIMENTAL

Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Intervention Type: DEVICE

Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.

Pivotal - Roll-In

First patient treated by each physician in the pivotal phase.

Group Type: EXPERIMENTAL

Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Intervention Type: DEVICE

Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.

Pivotal - Paroxysmal AF

Non roll-in patients with paroxysmal AF (intermittent AF).

Group Type: EXPERIMENTAL

Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Intervention Type: DEVICE

Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.

Pivotal - Persistent AF

Non roll-in patients with persistent AF (AF that lasts longer than 7 days).

Group Type: EXPERIMENTAL

Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Intervention Type: DEVICE

Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.

Interventions

Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.

2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:

1. Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:

1. physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and

2. at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment OR

2. Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:

1. physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and

2. any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment

3. Age 18 through 80 years old (or older than 18 if required by local law)

Exclusion Criteria

1. Long-standing persistent AF (continuous AF that is sustained >12 months)

2. Left atrial diameter > 5.0 cm (anteroposterior)

3. Prior left atrial ablation or surgical procedure (including left atrial appendage closures)

4. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period

5. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure

6. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)

7. Presence of any pulmonary vein stents

8. Presence of any pre-existing pulmonary vein stenosis

9. Pre-existing hemidiaphragmatic paralysis

10. Presence of any cardiac valve prosthesis

11. Moderate to severe mitral valve stenosis

12. More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)

13. Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date

14. Unstable angina

15. NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. TTE)

16. Primary pulmonary hypertension

17. Rheumatic heart disease

18. Thrombocytosis, thrombocytopenia

19. Any condition contraindicating chronic anticoagulation

20. Active systemic infection

21. Hypertrophic cardiomyopathy

22. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity

23. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date

24. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure

25. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence

26. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed

27. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic

28. Known allergies or hypersensitivities to adhesives

29. Unwilling or unable to comply fully with study procedures and follow-up

30. Unable to provide own informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atul Verma, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Grandview Medical Center

Birmingham, Alabama, United States

Medical Center of the Rockies

Loveland, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

BayCare Saint Joseph's Hospital

Tampa, Florida, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Northwestern University Hospital

Chicago, Illinois, United States

Iowa Heart Center

Des Moines, Iowa, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Southcoast Health System

Fall River, Massachusetts, United States

Spectrum Health

Grand Rapids, Michigan, United States

Beaumont Hospital

Royal Oak, Michigan, United States

Mayo Clinic (Rochester MN)

Rochester, Minnesota, United States

Saint Luke's Mid America Heart Institute

Kansas City, Missouri, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Northwell Health - North Shore University Hospital

Manhasset, New York, United States

NYU Langone Health - Heart Rhythm Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Doylestown Hospital

Doylestown, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center- UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

St. David's Medical Center

Austin, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Swedish Medical Center Cherry Hill

Seattle, Washington, United States

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Ordensklinikum Linz GmbH / Elisabethinen

Linz, , Austria

AZ Sint-Jan Brugge-Oostende av

Bruges, , Belgium

Vancouver General Hospital

Vancouver, British Columbia, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, Canada

CMC - Clinique Ambroise Paré

Neuilly-sur-Seine, , France

Hirosaki University Hospital

Hirosaki, Aomori, Japan

University of Fukui Hospital

Yoshida-gun, Fukui, Japan

Tokyo Medical and Dental University, Medical Hospital

Bunkyō-Ku, Tokyo, Japan

Jikei University

Minato-Ku, Tokyo, Japan

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Countries

United States; Australia; Austria; Belgium; Canada; France; Japan; Netherlands; Spain

References

Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Onal B, Cerkvenik J, Tada H, DeLurgio DB; PULSED AF Investigators. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023 May 9;147(19):1422-1432. doi: 10.1161/CIRCULATIONAHA.123.063988. Epub 2023 Mar 6.

Reference Type: RESULT

PMID: 36877118 (View on PubMed)

Verma A, Boersma L, Haines DE, Natale A, Marchlinski FE, Sanders P, Calkins H, Packer DL, Hummel J, Onal B, Rosen S, Kuck KH, Hindricks G, Wilsmore B. First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial. Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010168. doi: 10.1161/CIRCEP.121.010168. Epub 2021 Dec 29.

Reference Type: RESULT

PMID: 34964367 (View on PubMed)

Yamane T, Sasano T, Tomita H, Aoyama D, Miyazaki S, Takigawa M, Kimura M, Itoh T, Yamashita S, Selma JM, Cerkvenik J, Verma A, Tada H; PULSED AF Investigators. Safety, efficacy, and quality of life outcomes of pulsed field ablation in Japanese patients with atrial fibrillation: results from the PULSED AF trial. J Interv Card Electrophysiol. 2025 Jan;68(1):149-157. doi: 10.1007/s10840-024-01912-w. Epub 2024 Sep 7.

Reference Type: DERIVED

PMID: 39243306 (View on PubMed)

Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Tada H, Hoyt RH, Irwin JM, Andrade J, Cerkvenik J, Selma J, DeLurgio DB; PULSED AF Investigators. Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial. Heart Rhythm. 2023 Sep;20(9):1238-1245. doi: 10.1016/j.hrthm.2023.05.018. Epub 2023 May 19.

Reference Type: DERIVED

PMID: 37211146 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: version 7

View Document

Document Type: Study Protocol and Statistical Analysis Plan: version 6

View Document

Document Type: Study Protocol and Statistical Analysis Plan: version 3

View Document

Document Type: Study Protocol and Statistical Analysis Plan: version 2

View Document

Other Identifiers

PULSED AF

Identifier Type: -

Identifier Source: org_study_id