Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198701
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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

Layout table for study information
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


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 :
  1. 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)

  2. 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:
  1. 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 ]
  2. 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:

    1. Inability to isolate all accessible targeted pulmonary veins (assessed for entrance block and, where assessable, exit block) during the index ablation procedure.
    2. Ablation using a non-study device in the left atrium.

    Acute procedural success is the opposite of acute procedural failure.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:

    1. Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:

      1. physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and
      2. at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment OR
    2. Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:

      1. physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and
      2. 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
  3. Age 18 through 80 years old (or older than 18 if required by local law)

Exclusion Criteria:

  1. Long-standing persistent AF (continuous AF that is sustained >12 months)
  2. Left atrial diameter > 5.0 cm (anteroposterior)
  3. Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
  4. 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
  5. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
  6. 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)
  7. Presence of any pulmonary vein stents
  8. Presence of any pre-existing pulmonary vein stenosis
  9. Pre-existing hemidiaphragmatic paralysis
  10. Presence of any cardiac valve prosthesis
  11. Moderate to severe mitral valve stenosis
  12. More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
  13. Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
  14. Unstable angina
  15. 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)
  16. Primary pulmonary hypertension
  17. Rheumatic heart disease
  18. Thrombocytosis, thrombocytopenia
  19. Any condition contraindicating chronic anticoagulation
  20. Active systemic infection
  21. Hypertrophic cardiomyopathy
  22. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
  23. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
  24. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
  25. 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
  26. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
  27. 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
  28. Known allergies or hypersensitivities to adhesives
  29. Unwilling or unable to comply fully with study procedures and follow-up
  30. 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
Layout table for location 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 Show 41 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Layout table for investigator information
Principal Investigator: Atul Verma, MD Southlake Regional Health Centre
Layout table for additonal information
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: September 27, 2021
Last Verified: September 2021

Layout table for additional information
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:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes