Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Registration Number
- NCT04198701
- Lead Sponsor
- Medtronic Cardiac Ablation Solutions
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 421
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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.
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A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
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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
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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
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Age 18 through 80 years old (or older than 18 if required by local law)
- 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
- Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
- 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
- Known allergies or hypersensitivities to adhesives
- Unwilling or unable to comply fully with study procedures and follow-up
- Unable to provide own informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Pilot Medtronic PulseSelect Pulsed Field Ablation (PFA) System First group of patients enrolled in the study. Pivotal - Paroxysmal AF Medtronic PulseSelect Pulsed Field Ablation (PFA) System Non roll-in patients with paroxysmal AF (intermittent AF). Pivotal - Roll-In Medtronic PulseSelect Pulsed Field Ablation (PFA) System First patient treated by each physician in the pivotal phase. Pivotal - Persistent AF Medtronic PulseSelect Pulsed Field Ablation (PFA) System Non roll-in patients with persistent AF (AF that lasts longer than 7 days).
- Primary Outcome Measures
Name Time Method Safety: Number of Participants With at Least One Primary Safety Event up to 6 months 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)Effectiveness: Number of Participants With Treatment Success. up to 12 months 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.
- Secondary Outcome Measures
Name Time Method Quality of Life - Change in EQ-5D Score Baseline to 12 months post-ablation Change in EQ-5D score (12-month score - baseline score). The Euroqol EQ-5D questionnaire (5L version) is a standardized instrument for measuring general health status. The Euroqol EQ-5D questionnaire (which consists of a 5-question survey and a visual analog scale) has a composite score based on the 5-question survey that ranges from 0 (least healthy) to 1 (most healthy).
Quality of Life - Change in AFEQT Score Baseline to 12 months post-ablation Change in AFEQT score (12-month score - baseline score). The AFEQT questionnaire is an atrial fibrillation (AF) specific health-related quality of life questionnaire to assess the impact of AF on a subject's life. The overall score ranges from 0 - 100, with 0 corresponding to complete disability and 100 corresponding to no disability
Trial Locations
- Locations (41)
Northwell Health - North Shore University Hospital
🇺🇸Manhasset, New York, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center- UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Swedish Medical Center Cherry Hill
🇺🇸Seattle, Washington, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Southcoast Health System
🇺🇸Fall River, Massachusetts, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Ordensklinikum Linz GmbH / Elisabethinen
🇦🇹Linz, Austria
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
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
AZ Sint-Jan Brugge-Oostende av
🇧🇪Brugge, Belgium
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦Québec City, Quebec, Canada
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
CMC - Clinique Ambroise Paré
🇫🇷Neuilly-sur-Seine, France
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Hirosaki University Hospital
🇯🇵Hirosaki, Aomori, Japan
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Providence Saint Vincent Medical Center
🇺🇸Portland, Oregon, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Emory Saint Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University Hospital
🇺🇸Chicago, Illinois, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Mayo Clinic (Rochester MN)
🇺🇸Rochester, Minnesota, United States
NYU Langone Health - Heart Rhythm Center
🇺🇸New York, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
BayCare Saint Joseph's Hospital
🇺🇸Tampa, Florida, United States
Saint Luke's Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
St. David's Medical Center
🇺🇸Austin, Texas, United States
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Montefiore Medical Center
🇺🇸Bronx, New York, United States