Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Ablation Solutions
- Enrollment
- 421
- Locations
- 41
- Primary Endpoint
- Safety: Number of Participants With at Least One Primary Safety Event
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Safety: Number of Participants With at Least One Primary Safety Event
Time Frame: 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.
Time Frame: 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 Outcomes
- 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)