Atrial FibrillationDISRUPT-AFNCT06335082
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
An observational study of Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC at 36 sites in United States.
Trial summary
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulsed Field Ablation
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 36 sitesUnited States
- Study dates
- 24 Apr 2024to 30 Jan 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.
Who may be able to join
- Patients who, in the opinion of the Investigator, are candidates for ablation for AF
- Plans to undergo an ablation procedure using the FARAPULSE Pulsed Field Ablation System manufactured by Boston Scientific (as of July 1, 2026, patients enrolled must have procedures completed using the OPAL HDx mapping system, unless the subject is participating in a sub-study not requiring OPAL usage)
- De Novo or repeat procedure using the FARAPULSE Pulse Field Ablation System.
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the registry
Who cannot join
- Enrolled in an investigational drug or device trial, or any trial that dictates the treatment plan without prior approval from Sponsor
- Currently receiving inotropic or mechanical support for Stage IV congestive heart failure, cardiogenic and/or septic shock.
- In the opinion of the Investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the Investigator
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
United States36 sites
HCA Research Institute Mission Hospital
Asheville, North Carolina, 28801
Ascension Texas Cardiovascular
Austin, Texas, 78705
Texas Cardiac Arrhythmia Research Foundation (St. Davids)
Austin, Texas, 78705
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35243
St. Luke's Medical Center
Boise, Idaho, 83712
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The Christ Hospital - Heart & Vascular
Cincinnati, Ohio, 45219
OhioHealth Research Institute
Columbus, Ohio, 43214
HCA Medical City Dallas
Dallas, Texas, 75243
The Arrythmia Center of South Florida
Delray Beach, Florida, 33484
HCA Medical City Fort Worth
Fort Worth, Texas, 76104
Endeavor Health (Northshore)
Glenview, Illinois, 60026
East Carolina University
Greenville, North Carolina, 27834
The Heart Rhythm Center of Mississippi
Gulfport, Mississippi, 39502
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, 08035
Ascension St Vincent -Indianapolis Ascension Health
Indianapolis, Indiana, 46184
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Ascension St. Vincent's
Jacksonville, Florida, 32204
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
South Denver Cardiology Associates
Littleton, Colorado, 80120
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Norton Heart & Vascular Institute
Louisville, Kentucky, 40205
HCA Florida Mercy Hospital
Miami, Florida, 33133
Ascension St. Thomas Nashville
Nashville, Tennessee, 37203
HCA - Trident Medical Center
North Charleston, South Carolina, 29406
The Valley Hospital
Paramus, New Jersey, 07652
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
HCA Research Institute - Chippenham Hospital
Richmond, Virginia, 23225
St. Mark's Hospital
Salt Lake City, Utah, 84124
Sutter Health - California Pacific Medical Center
San Francisco, California, 94109
Sarasota Memorial Hospital
Sarasota, Florida, 34239
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, 75701
Community Memorial Health Systems
Ventura, California, 93003
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50026
WellSpan Health
York, Pennsylvania, 17402
About this study
Official title: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse Pulsed Field Ablation Technology for Atrial Fibrillation
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF).
Read the detailed description
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). All types of AF including paroxysmal, persistent and long standing persistent may be included.
The registry has three cohorts: 1) Acute Arm, 2) Symptomatic Monitoring Only Arm, and 3) Full Monitoring Arm. In the Acute Arm, patient assessments will occur at pre- procedure and procedure visits. In both the Symptomatic Monitoring Only Arm and the Full Monitoring Arm, patient assessments will occur at pre- procedure, procedure, 3 months, and 1 year post ablation. Additionally, the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation.
Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care. Sites can only participate in one arm.
The primary purpose of the registry is to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of pulsed field ablation (PFA) in the treatment of patients with AF. Also, to assess the effect of PFA technology implementation on practice patterns, operational workflow and operator experience.
The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulsed Field Ablation
- Keywords
- paroxysmal atrial fibrillation, persistent atrial fibrillation, long-standing persistent atrial fibrillation, pulse field ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field AblationDevice
Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)
| Study group | Role | What they receive |
|---|---|---|
| Acute Arm | Data will be collected at pre-ablation/baseline and at time of the ablation procedure. Sites should follow the subjects per their standard of care and at a minimum report any acute onset procedure or device-related complications through 30-days post procedure. Data collection will include procedural workflow, procedural outcomes, and acute onset procedure or device-related complications through 30 days. Receives: Device: Pulsed Field Ablation | |
| Symptomatic Monitoring Only Arm (SMO) | Data will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit and 12-Months post-ablation (monitoring is triggered for symptomatic recurrences only). Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, and symptomatic recurrence. Receives: Device: Pulsed Field Ablation | |
| Full Monitoring Arm (FM) | Data will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit, interim continuous monitoring for asymptomatic arrhythmia recurrence at 6- and 12-Months post-ablation as well as monitoring as needed for symptomatic recurrences, and a 12-Month post-ablation office visit. Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, symptomatic recurrence as well as asymptomatic recurrence. Receives: Device: Pulsed Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term effectiveness
Freedom from atrial arrhythmia recurrence post 90-day blanking period
Measured: 12 months
Long-term safety
Rate of long-term safety events defined as procedure or device related reportable events (complications) that occur greater than 30 days post ablation. Data for this endpoint will be evaluated from the pooled results of the SMO and FM study arms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start24 Apr 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335082
- Sponsor's protocol ID
- DISRUPT-AF
- Acronym
- DISRUPT-AF
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Al-Ahmad A, Osorio J, Day J, Wasserlauf J, Nair D, Eckart R, Campbell D, Dukes J, Cuoco F, Costello J, Zagrodzky J, Kessler D, Morales G, Rajendra A, Oza S, Barakat A, Magnano A, Amin A, Silverstein J, Thosani A, Bezenek SM, Zei P, Dai C, Natale A, Horton R; DISRUPT AF Investigators. Patient and Procedural Factors Associated With Same-Day Discharge Following Pulsed Field Ablation for Atrial Fibrillation: Insights From the DISRUPT-AF Registry. J Cardiovasc Electrophysiol. 2026 Jan;37(1):149-156. doi: 10.1111/jce.70210. Epub 2025 Dec 2.
PubMed 41331670
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse Pulsed Field Ablation Technology for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06335082
- Acronym / sponsor ID
- DISRUPT-AF / DISRUPT-AF
- Conditions
- Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, persistent atrial fibrillation, long-standing persistent atrial fibrillation, pulse field ablation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLCUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF).
Detailed description
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). All types of AF including paroxysmal, persistent and long standing persistent may be included.
The registry has three cohorts: 1) Acute Arm, 2) Symptomatic Monitoring Only Arm, and 3) Full Monitoring Arm. In the Acute Arm, patient assessments will occur at pre- procedure and procedure visits. In both the Symptomatic Monitoring Only Arm and the Full Monitoring Arm, patient assessments will occur at pre- procedure, procedure, 3 months, and 1 year post ablation. Additionally, the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation.
Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care. Sites can only participate in one arm.
The primary purpose of the registry is to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of pulsed field ablation (PFA) in the treatment of patients with AF. Also, to assess the effect of PFA technology implementation on practice patterns, operational workflow and operator experience.
The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Arm | – | Device: Pulsed Field AblationData will be collected at pre-ablation/baseline and at time of the ablation procedure. Sites should follow the subjects per their standard of care and at a minimum report any acute onset procedure or device-related complications through 30-days post procedure. Data collection will include procedural workflow, procedural outcomes, and acute onset procedure or device-related complications through 30 days. |
| Symptomatic Monitoring Only Arm (SMO) | – | Device: Pulsed Field AblationData will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit and 12-Months post-ablation (monitoring is triggered for symptomatic recurrences only). Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, and symptomatic recurrence. |
| Full Monitoring Arm (FM) | – | Device: Pulsed Field AblationData will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit, interim continuous monitoring for asymptomatic arrhythmia recurrence at 6- and 12-Months post-ablation as well as monitoring as needed for symptomatic recurrences, and a 12-Month post-ablation office visit. Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, symptomatic recurrence as well as asymptomatic recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.
Key inclusion criteria (5 listed)
- Patients who, in the opinion of the Investigator, are candidates for ablation for AF
- Plans to undergo an ablation procedure using the FARAPULSE Pulsed Field Ablation System manufactured by Boston Scientific (as of July 1, 2026, patients enrolled must have procedures completed using the OPAL HDx mapping system, unless the subject is participating in a sub-study not requiring OPAL usage)
- De Novo or repeat procedure using the FARAPULSE Pulse Field Ablation System.
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the registry
Key exclusion criteria (3 listed)
- Enrolled in an investigational drug or device trial, or any trial that dictates the treatment plan without prior approval from Sponsor
- Currently receiving inotropic or mechanical support for Stage IV congestive heart failure, cardiogenic and/or septic shock.
- In the opinion of the Investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the Investigator
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 |
|---|---|---|
| Pulsed Field AblationAblation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF) | Device | Acute Arm, Full Monitoring Arm (FM), Symptomatic Monitoring Only Arm (SMO) |
Primary outcome
Long term effectiveness
Time frame: 12 months
Freedom from atrial arrhythmia recurrence post 90-day blanking period
Long-term safety
Time frame: 12 months
Rate of long-term safety events defined as procedure or device related reportable events (complications) that occur greater than 30 days post ablation. Data for this endpoint will be evaluated from the pooled results of the SMO and FM study arms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 41331670Al-Ahmad A, Osorio J, Day J, Wasserlauf J, Nair D, Eckart R, Campbell D, Dukes J, Cuoco F, Costello J, Zagrodzky J, Kessler D, Morales G, Rajendra A, Oza S, Barakat A, Magnano A, Amin A, Silverstein J, Thosani A, Bezenek SM, Zei P, Dai C, Natale A, Horton R; DISRUPT AF Investigators. Patient and Procedural Factors Associated With Same-Day Discharge Following Pulsed Field Ablation for Atrial Fibrillation: Insights From the DISRUPT-AF Registry. J Cardiovasc Electrophysiol. 2026 Jan;37(1):149-156. doi: 10.1111/jce.70210. Epub 2025 Dec 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC at 36 sites in United States.
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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Long term effectiveness (time frame: 12 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 NCT06335082, which also lists 1 linked publication.
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 27 Aug 2026.