Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

NCT04198701 | Completed Results FDA Device

• 1 other identifier: PULSED AF
• Study Type: interventional
• Target: 421
• Locations: 8 countries
• Sites: 40

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

Outcome Measures

Primary Outcomes (2)

• Safety: Number of Participants With at Least One Primary Safety Event

  Primary safety events are: Within 6 months post-ablation: * Pulmonary vein stenosis (≥70% diameter reduction) * Phrenic nerve injury/diaphragmatic paralysis (ongoing at 6 months) * Atrioesophageal fistula Within 30 days of ablation procedure: * Cardiac tamponade/perforation * Cerebrovascular accident * Major bleeding requiring transfusion * Myocardial infarction * Pericarditis requiring intervention * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Vascular access complications requiring intervention * Systemic/pulmonary embolism requiring intervention * Pulmonary edema * Death * Any PulseSelect PFA System-related or PFA procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalization for more than 48 hours (excluding recurrent AF/AFL/AT)

  up to 6 months

• Effectiveness: Number of Participants With Treatment Success.

  Treatment success is defined as freedom from treatment failure. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic patient activated ambulatory monitoring transmissions through 12 months, and 12-lead ECGs at all follow up visits. Treatment failure is defined as any of the following components: * Acute procedural failure * Documented AF/AT/AFL on Holter/patient activated ambulatory monitoring/12-lead ECG after the 90-day post-ablation blanking period. * Any subsequent AF surgery or ablation in the left atrium, except for one repeat PVI ablation using PFA within the 90-day blanking period. * Direct current cardioversion for atrial tachyarrhythmia recurrences after the 90-day blanking period. * Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90-day blanking period.

  up to 12 months

Secondary Outcomes (2)

• Quality of Life - Change in EQ-5D Score

  Baseline to 12 months post-ablation

• Quality of Life - Change in AFEQT Score

  Baseline to 12 months post-ablation

Other Outcomes (2)

• Pilot Phase Safety: Number of Participants With a PFA System-related and PFA Procedure-related Serious Adverse Event (SAE) Within 30 Days Post-ablation.

  30 days

• Pilot Phase Effectiveness: Number of Participants With Acute Procedural Success of PVI Ablation With the PFA System.

  Acute (day of procedure)

Study Arms (4)

Pilot

EXPERIMENTAL

First group of patients enrolled in the study.

Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Pivotal - Roll-In

EXPERIMENTAL

First patient treated by each physician in the pivotal phase.

Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Pivotal - Paroxysmal AF

EXPERIMENTAL

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

Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Pivotal - Persistent AF

EXPERIMENTAL

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

Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Interventions

Medtronic PulseSelect Pulsed Field Ablation (PFA) System 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.

Pilot; Pivotal - Paroxysmal AF; Pivotal - Persistent AF; Pivotal - Roll-In

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
• Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
• physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and
• at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment OR
• Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
• physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and
• 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
• Age 18 through 80 years old (or older than 18 if required by local law)

You may not qualify if:

• Long-standing persistent AF (continuous AF that is sustained \>12 months)
• Left atrial diameter \> 5.0 cm (anteroposterior)
• Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
• 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
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• 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)
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Presence of any cardiac valve prosthesis
• Moderate to severe mitral valve stenosis
• More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
• Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
• Unstable angina
• 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)

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (41)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

BayCare Saint Joseph's Hospital

Tampa, Florida, 33607, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University Hospital

Chicago, Illinois, 60611, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Southcoast Health System

Fall River, Massachusetts, 02720, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic (Rochester MN)

Rochester, Minnesota, 55902, United States

Location

Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Northwell Health - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

NYU Langone Health - Heart Rhythm Center

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Mission Hospital

Asheville, North Carolina, 28803, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Providence Saint Vincent Medical Center

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

University of Pittsburgh Medical Center- UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

St. David's Medical Center

Austin, Texas, 78705, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center Cherry Hill

Seattle, Washington, 98122, United States

Location

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Location

Ordensklinikum Linz GmbH / Elisabethinen

Linz, 4010, Austria

Location

AZ Sint-Jan Brugge-Oostende av

Bruges, 8000, Belgium

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

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

Québec, Quebec, G1V4G5, Canada

Location

CMC - Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

Hirosaki University Hospital

Hirosaki, Aomori, 036-8563, Japan

Location

University of Fukui Hospital

Yoshida-gun, Fukui, 910-1193, Japan

Location

Tokyo Medical and Dental University, Medical Hospital

Bunkyō-Ku, Tokyo, 113-8519, Japan

Location

Jikei University

Minato-Ku, Tokyo, 105-8471, Japan

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (4)

• 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.

  PMID: 36877118 RESULT

• 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.

  PMID: 34964367 RESULT

• 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.

  PMID: 39243306 DERIVED

• 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.

  PMID: 37211146 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: Medtronic, Inc.

medtroniccrmtrials@medtronic.com

800-328-2518

Study Officials

• Atul Verma, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study begins with a Pilot Phase, followed sequentially by a Pivotal Phase consisting of 3 arms enrolling simultaneously: Roll-in, Paroxysmal AF, Persistent AF

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: December 10, 2019
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: February 13, 2025
• Results First Posted: December 13, 2023

Record last verified: 2025-02

Locations

US (27); AU (1); NL (1); ES (1); CA (4); FR (1); JP (4); BE (1)