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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04198701




Registration number
NCT04198701
Ethics application status
Date submitted
10/12/2019
Date registered
13/12/2019
Date last updated
20/02/2024

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 PulseSelect Pulsed Field Ablation (PFA) System

Experimental: Pilot - First group of patients enrolled in the study.

Experimental: Pivotal - Roll-In - First patient treated by each physician in the pivotal phase.

Experimental: Pivotal - Paroxysmal AF - Non roll-in patients with paroxysmal AF (intermittent AF).

Experimental: Pivotal - Persistent AF - Non roll-in patients with persistent AF (AF that lasts longer than 7 days).


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

Outcomes
Primary outcome [1] 0 0
Safety: Number of Participants With at Least One Primary Safety Event
Timepoint [1] 0 0
up to 6 months
Primary outcome [2] 0 0
Effectiveness: Number of Participants With Treatment Success.
Timepoint [2] 0 0
up to 12 months
Secondary outcome [1] 0 0
Quality of Life - Change in EQ-5D Score
Timepoint [1] 0 0
Baseline to 12 months post-ablation
Secondary outcome [2] 0 0
Quality of Life - Change in AFEQT Score
Timepoint [2] 0 0
Baseline to 12 months post-ablation

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
80 Years
Sex
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2022
Sample size
Target
Accrual to date
Final
421
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
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Austria
State/province [22] 0 0
Linz
Country [23] 0 0
Belgium
State/province [23] 0 0
Brugge
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
France
State/province [27] 0 0
Neuilly-sur-Seine
Country [28] 0 0
Japan
State/province [28] 0 0
Aomori
Country [29] 0 0
Japan
State/province [29] 0 0
Fukui
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nieuwegein
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04198701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Atul Verma, MD
Address 0 0
McGill University Health Centre/Research Institute of the McGill University Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries