Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04198701

Run by

Medtronic Cardiac Ablation Solutions

People needed

421

Starts

2019-12-10

Expected to finish

2022-11-28

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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)
• Primary pulmonary hypertension
• Rheumatic heart disease
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• Active systemic infection
• Hypertrophic cardiomyopathy
• Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
• History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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