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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04198701




Registration number
NCT04198701
Ethics application status
Date submitted
10/12/2019
Date registered
13/12/2019
Date last updated
9/07/2020

Titles & IDs
Public title
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
Scientific title
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
Secondary ID [1] 0 0
PULSED AF
Universal Trial Number (UTN)
Trial acronym
PULSED AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic Pulsed Field Ablation (PFA) System

Experimental: Pilot -


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Assess the incidence of PFA system-related and PFA procedure-related serious adverse events (SAEs) within 30 days post-ablation.
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Effectiveness: Assess the acute procedural success of PVI ablation with the PFA system. - Acute procedural failure is defined as:
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 to isolate any pulmonary vein.
Acute procedural success is the opposite of acute procedural failure.
Timepoint [2] 0 0
Acute (day of procedure)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
- New Lambton Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Netherlands
State/province [3] 0 0
Nieuwegein

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04198701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Atul Verma, MD
Address 0 0
Southlake Regional Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Josh Treadway
Address 0 0
Country 0 0
Phone 0 0
763-526-1832
Fax 0 0
Email 0 0
josh.b.treadway@medtronic.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04198701