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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 : July 9, 2020
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 study will provide first in human insights into clinical safety and device function of the Medtronic PFA system for pulmonary vein isolation (PVI) as a treatment for AF.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Medtronic Pulsed Field Ablation (PFA) System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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 : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilot Device: Medtronic 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 PFA system.




Primary Outcome Measures :
  1. 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. 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:

    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 to isolate any pulmonary vein.

    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.


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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:

  1. Failure of at least one antiarrhythmic drug 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 with the following documentation:

    1. Paroxysmal: (1) physician's note indicating symptoms consistent with recurrent self-terminating or terminating with intervention (within 7 days) AF or paroxysmal AF; and (2) any ECG documented AF episode(s) within 12 months prior to enrollment

      OR

    2. Persistent: (1) physician's note indicating symptoms consistent with continuous AF episode lasting longer than 7 days but less than 1 year; and (2) any 24-hour continuous ECG recording documenting persistent AF within 6 months of enrollment; OR (2) two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart
  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 left atrial appendage (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, percutaneous coronary intervention (PCI) / Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3-month interval preceding the consent date
  14. Unstable angina
  15. New York Heart Association (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 transient ischemic attacks (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 child bearing 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
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Contact: Josh Treadway 763-526-1832 josh.b.treadway@medtronic.com

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: John Hummel, MD         
Principal Investigator: John Hummel, MD         
Australia, New South Wales
John Hunter Hospital Active, not recruiting
New Lambton Heights, New South Wales, Australia
Canada, Ontario
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada
Contact: Atul Verma, MD         
Principal Investigator: Atul Verma, MD         
Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3435 CM
Contact: Lucas Boersma, MD, PhD         
Principal Investigator: Lucas Boersma, MD, PhD         
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Atul Verma, MD Southlake Regional Health Centre
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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: July 9, 2020
Last Verified: July 2020

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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