Trial record 1 of 1 for:
pulsed field ablation beaumont | Atrial Fibrillation
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF)
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| ClinicalTrials.gov Identifier: NCT04198701 |
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Recruitment Status :
Recruiting
First Posted : December 13, 2019
Last Update Posted : August 16, 2021
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Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | 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 |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF |
| Actual Study Start Date : | December 10, 2019 |
| Estimated Primary Completion Date : | October 2022 |
| Estimated Study Completion Date : | October 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
| Arm | Intervention/treatment |
|---|---|
| Experimental: Pilot |
Device: 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. |
| Experimental: Pivotal - Roll-In |
Device: 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. |
| Experimental: Pivotal - Paroxysmal AF |
Device: 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. |
| Experimental: Pivotal - Persistent AF |
Device: 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. |
Primary Outcome Measures :
- Safety: Demonstrate an acceptable safety profile of PVI ablation with the PulseSelect PFA System. The following PFA System-related and PFA procedure-related serious adverse events (SAEs) will be considered a primary safety event: [ Time Frame: up to 6 months ]
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: Demonstrate an acceptable chronic effectiveness of PVI ablation with the PulseSelect PFA System, based on freedom from treatment failure. [ 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.
Other Outcome Measures:
- Pilot Phase Safety: Assess the incidence of PFA System-related and PFA procedure-related serious adverse events (SAEs) within 30 days post-ablation. [ Time Frame: 30 days ]
- Pilot Phase Effectiveness: Assess the acute procedural success of PVI ablation with the PFA System. [ Time Frame: Acute (day of procedure) ]
Acute procedural failure is defined as the occurrence of any of the following:
- Inability to isolate all accessible targeted pulmonary veins (assessed for entrance block and, where assessable, exit block) during the index ablation procedure.
- Ablation using a non-study device in the left atrium.
Acute procedural success is the opposite of acute procedural failure.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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)
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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198701
Contacts
| Contact: Josh Treadway | 763-526-1832 | josh.b.treadway@medtronic.com | |
| Contact: Jen Diouf | 763-526-2587 | jen.r.diouf@medtronic.com |
Locations
Show 36 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
| Principal Investigator: | Atul Verma, MD | Southlake Regional Health Centre |
| Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
| ClinicalTrials.gov Identifier: | NCT04198701 |
| Other Study ID Numbers: |
PULSED AF |
| First Posted: | December 13, 2019 Key Record Dates |
| Last Update Posted: | August 16, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |