Atrial FibrillationPULSED AFNCT04198701
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
A study testing Medtronic PulseSelect Pulsed Field Ablation (PFA) System in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 41 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 41 sitesin 9 countries
- Study dates
- 10 Dec 2019to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
- 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
- Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
Show all 9Show fewer
- 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
- Age 18 through 80 years old (or older than 18 if required by local law)
Who cannot join
- 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)
Show all 30Show fewer
- 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
Trial locations and contacts
41 sites in 9 countries.
41 sites in 9 countries
United States27 sites
Mission Hospital
Asheville, North Carolina, 28803
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30322
St. David's Medical Center
Austin, Texas, 78705
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Grandview Medical Center
Birmingham, Alabama, 35243
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Northwestern University Hospital
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Iowa Heart Center
Des Moines, Iowa, 50314
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Southcoast Health System
Fall River, Massachusetts, 02720
Spectrum Health
Grand Rapids, Michigan, 49503
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
Medical Center of the Rockies
Loveland, Colorado, 80538
Northwell Health - North Shore University Hospital
Manhasset, New York, 11030
NYU Langone Health - Heart Rhythm Center
New York, New York, 10016
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center- UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
The Valley Hospital
Ridgewood, New Jersey, 07450
Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55902
Beaumont Hospital
Royal Oak, Michigan, 48073
Swedish Medical Center Cherry Hill
Seattle, Washington, 98122
BayCare Saint Joseph's Hospital
Tampa, Florida, 33607
Montefiore Medical Center
The Bronx, New York, 10467
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada4 sites
McGill University Health Centre
Montreal, Quebec, H3G1A4
Southlake Regional Health Centre
Newmarket, Ontario
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V4G5
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Japan4 sites
Tokyo Medical and Dental University, Medical Hospital
Bunkyō-Ku, Tokyo, 113-8519
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563
Jikei University
Minato-Ku, Tokyo, 105-8471
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic PulseSelect Pulsed Field Ablation (PFA) SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Experimental | First group of patients enrolled in the study. Receives: Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System |
| Pivotal - Roll-In | Experimental | First patient treated by each physician in the pivotal phase. Receives: Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System |
| Pivotal - Paroxysmal AF | Experimental | Non roll-in patients with paroxysmal AF (intermittent AF). Receives: Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System |
| Pivotal - Persistent AF | Experimental | Non roll-in patients with persistent AF (AF that lasts longer than 7 days). Receives: Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants With at Least One Primary Safety Event
Primary safety events are:
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)
Measured: up to 6 months
Effectiveness: Number of Participants With Treatment Success.
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.
Measured: up to 12 months
Secondary outcomes (2)
Quality of Life - Change in EQ-5D Score
Change in EQ-5D score (12-month score - baseline score). The Euroqol EQ-5D questionnaire (5L version) is a standardized instrument for measuring general health status. The Euroqol EQ-5D questionnaire (which consists of a 5-question survey and a visual analog scale) has a composite score based on the 5-question survey that ranges from 0 (least healthy) to 1 (most healthy).
Measured: Baseline to 12 months post-ablation
Quality of Life - Change in AFEQT Score
Change in AFEQT score (12-month score - baseline score). The AFEQT questionnaire is an atrial fibrillation (AF) specific health-related quality of life questionnaire to assess the impact of AF on a subject's life. The overall score ranges from 0 - 100, with 0 corresponding to complete disability and 100 corresponding to no disability
Measured: Baseline to 12 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start10 Dec 2019
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atul Verma, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198701
- Sponsor's protocol ID
- PULSED AF
- Acronym
- PULSED AF
- Status last verified
- Feb 2025
- First submitted
- 10 Dec 2019
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Onal B, Cerkvenik J, Tada H, DeLurgio DB; PULSED AF Investigators. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023 May 9;147(19):1422-1432. doi: 10.1161/CIRCULATIONAHA.123.063988. Epub 2023 Mar 6.
PubMed 36877118Verma A, Boersma L, Haines DE, Natale A, Marchlinski FE, Sanders P, Calkins H, Packer DL, Hummel J, Onal B, Rosen S, Kuck KH, Hindricks G, Wilsmore B. First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial. Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010168. doi: 10.1161/CIRCEP.121.010168. Epub 2021 Dec 29.
PubMed 34964367Yamane T, Sasano T, Tomita H, Aoyama D, Miyazaki S, Takigawa M, Kimura M, Itoh T, Yamashita S, Selma JM, Cerkvenik J, Verma A, Tada H; PULSED AF Investigators. Safety, efficacy, and quality of life outcomes of pulsed field ablation in Japanese patients with atrial fibrillation: results from the PULSED AF trial. J Interv Card Electrophysiol. 2025 Jan;68(1):149-157. doi: 10.1007/s10840-024-01912-w. Epub 2024 Sep 7.
PubMed 39243306Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Tada H, Hoyt RH, Irwin JM, Andrade J, Cerkvenik J, Selma J, DeLurgio DB; PULSED AF Investigators. Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial. Heart Rhythm. 2023 Sep;20(9):1238-1245. doi: 10.1016/j.hrthm.2023.05.018. Epub 2023 May 19.
PubMed 37211146
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
- ClinicalTrials.gov ID
- NCT04198701
- Acronym / sponsor ID
- PULSED AF / PULSED AF
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Pilot | Experimental | Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) SystemFirst group of patients enrolled in the study. |
| Pivotal - Roll-In | Experimental | Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) SystemFirst patient treated by each physician in the pivotal phase. |
| Pivotal - Paroxysmal AF | Experimental | Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) SystemNon roll-in patients with paroxysmal AF (intermittent AF). |
| Pivotal - Persistent AF | Experimental | Device: Medtronic PulseSelect Pulsed Field Ablation (PFA) SystemNon roll-in patients with persistent AF (AF that lasts longer than 7 days). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
- Age 18 through 80 years old (or older than 18 if required by local law)
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic PulseSelect Pulsed Field Ablation (PFA) SystemAdult 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. | Device | Pilot, Pivotal - Paroxysmal AF, Pivotal - Persistent AF, Pivotal - Roll-In |
Primary outcome
Safety: Number of Participants With at Least One Primary Safety Event
Time frame: up to 6 months
Primary safety events are: 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: Number of Participants With Treatment Success.
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.
2 secondary outcomes
Quality of Life - Change in EQ-5D Score
Time frame: Baseline to 12 months post-ablation
Quality of Life - Change in AFEQT Score
Time frame: Baseline to 12 months post-ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36877118Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Onal B, Cerkvenik J, Tada H, DeLurgio DB; PULSED AF Investigators. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023 May 9;147(19):1422-1432. doi: 10.1161/CIRCULATIONAHA.123.063988. Epub 2023 Mar 6.
- Results publication: PubMed 34964367Verma A, Boersma L, Haines DE, Natale A, Marchlinski FE, Sanders P, Calkins H, Packer DL, Hummel J, Onal B, Rosen S, Kuck KH, Hindricks G, Wilsmore B. First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial. Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010168. doi: 10.1161/CIRCEP.121.010168. Epub 2021 Dec 29.
- Derived from this study: PubMed 39243306Yamane T, Sasano T, Tomita H, Aoyama D, Miyazaki S, Takigawa M, Kimura M, Itoh T, Yamashita S, Selma JM, Cerkvenik J, Verma A, Tada H; PULSED AF Investigators. Safety, efficacy, and quality of life outcomes of pulsed field ablation in Japanese patients with atrial fibrillation: results from the PULSED AF trial. J Interv Card Electrophysiol. 2025 Jan;68(1):149-157. doi: 10.1007/s10840-024-01912-w. Epub 2024 Sep 7.
- Derived from this study: PubMed 37211146Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Tada H, Hoyt RH, Irwin JM, Andrade J, Cerkvenik J, Selma J, DeLurgio DB; PULSED AF Investigators. Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial. Heart Rhythm. 2023 Sep;20(9):1238-1245. doi: 10.1016/j.hrthm.2023.05.018. Epub 2023 May 19.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Verma, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
41 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic PulseSelect Pulsed Field Ablation (PFA) System in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 41 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada, Japan, Australia, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants With at Least One Primary Safety Event (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198701, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.