Persistent Atrial FibrillationREPRESENT-PFNCT07535268
REPRESENT-PF Registry
An observational study of Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Vivek Reddy at 2 sites in United States.
Trial summary
This pragmatic, prospective, single-arm, multi-center, observational registry will evaluate the safety and effectiveness of PFA for the treatment of atrial fibrillation in underrepresented minority patients using FDA approved Boston Scientific PFA catheters; all data collected will be standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- FARAWAVE Pulsed Field Ablation Catheter
- Type of treatment
- Medical device
- How many people
- 275 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2026to 1 Mar 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: Racial or ethnic minorities defined based on modified National Institutes of Health (NIH) categories: Black or African American, American Indian/Alaska native, Asian, Hawaiian or other Pacific Islander, multiracial or of Hispanic, Latino/Latina origin.
Who may be able to join
- All consecutive patients classified as racial or ethnic minorities undergoing ablation using Boston Scientific FDA approved PFA catheters for AF will be included.
- De novo ablation for symptomatic paroxysmal and persistent AF (Age ≥ 18) (unless it is a repeat for a patient whose index procedure is also in the registry) who are deemed to be candidates for AF ablation by the investigator.
- Able and willing to participate in baseline and follow up evaluation over the study period
- Willing and able to provide informed consent, if applicable.
Who cannot join
- Enrolled in an investigational drug or device clinical trial or any other trial with outlined treatment plan
- Long standing persistent AF (AF > 1 year duration)
- Repeat ablation, unless index ablation procedure was in the REPRESENT-PF registry
- Any known contra-indication to ablation procedure at the discretion of the investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Betsy Ellsworth, MSN, ANP contact
United States2 sites, 2 recruiting
- Recruiting
The Mount Sinai Hospital
New York, New York, 10030
Devin Chamberlain, (646) 984-1049, devin.chamberlain@mountsinai.org
Joshua Lampert, MD
- Recruiting
Valley Health System
Winchester, Virginia, 22601
Lauren Peterson, lpeterso@valleyhealthlink.com
About this study
Official title: Prospective Multicenter Registry on the Clinical Outcomes and Safety of PFA for Atrial Fibrillation in Underrepresented Minorities (REPRESENT-PF Registry)
This pragmatic, prospective, single-arm, multi-center, observational registry will evaluate the safety and effectiveness of PFA for the treatment of atrial fibrillation in underrepresented minority patients using FDA approved Boston Scientific PFA catheters; all data collected will be standard of care.
Read the detailed description
Catheter ablation is an established treatment for atrial fibrillation (AF) and is increasingly being utilized as first line therapy in patients with symptomatic AF. Pulsed field ablation (PFA) is a novel transformative technology that has demonstrated an excellent safety profile owing to its ability to achieve preferential myocardial tissue ablation and improve workflow efficiencies while exhibiting at least comparable efficacy to conventional thermal ablation modalities. This development has significant public health implications given the increasing prevalence of AF with associated morbidity and mortality.
Historically, Blacks, Hispanics, Asians and other racial and ethnic minorities have been underrepresented in clinical trials on the management of AF and specifically catheter ablation. This is further compounded by the fact that racial and ethnic minorities experience higher rates of AF-related adverse events as compared to non-minorities while being significantly less likely to receive catheter ablation therapy.
A multitude of factors have been identified as potential contributors to both the reduced utilization of catheter ablation therapy for under-represented minorities, and the increased event rates. The significant paucity of data limits more in depth analysis. It is therefore evident that greater strides towards inclusivity are needed to expand upon the clinical evidence with hopes of improving care delivery to this population.
REPRESENT-PF is a pragmatic, prospective single-arm, multi-center, observational registry studying the safety and effectiveness of PFA in underrepresented minority patients indicated for atrial arrhythmia ablation performed with Boston Scientific FDA approved catheters. The study will include both paroxysmal and persistent patients with a 1- year follow up period.
Racial or ethnic minorities will be defined based on a modified National Institutes of Health (NIH) categories: Black or African American, American Indian/Alaska native, Asian, Hawaiian or other Pacific Islander, multiracial or of Hispanic, Latino/Latina origin.
- Being tested
- FARAWAVE Pulsed Field Ablation Catheter
- Keywords
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Pulsed 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.
FARAWAVE Pulsed Field Ablation CatheterDevice
The FARAWAVE Pulsed Field Ablation (PFA) Catheter is a component of the FARAPULSE PFA System. The FARAWAVE Catheter is an over-the-wire, multi-electrode catheter designed to deliver PFA energy to the distal section for cardiac ablation. The FARAWAVE Catheter is indicated for: 1) the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) 2) the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year) This device is FDA approved.
| Study group | Role | What they receive |
|---|---|---|
| Patients indicated for atrial arrhythmia ablation | All patients will receive standard of care treatment. Receives: Device: FARAWAVE Pulsed Field Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Serious Adverse Events
Assess device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure
The proportion of all Treatment Subjects and Attempt Subjects (combined PAF and PersAF cohort) with one or more device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure on or prior to the Day 60 Assessment, with an Onset Date following the procedure.
Measured: up to Day 60 Post Procedure
Chronic Treatment Success
Chronic treatment success is defined as freedom from any of the following through the Day 365:
- Arrhythmia: Occurrence of any detectable AF, AFL or AT
- Re-ablation: Any re-ablation for AF, AFL or AT at any time following the index procedure after the blanking period.
- Cardioversion: Any electrical cardioversion for AF, AFL or AT
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 posted17 Apr 2026
- Study start30 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Other
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535268
- Sponsor's protocol ID
- STUDY-25-01408
- Acronym
- REPRESENT-PF
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry on the Clinical Outcomes and Safety of PFA for Atrial Fibrillation in Underrepresented Minorities (REPRESENT-PF Registry)
- ClinicalTrials.gov ID
- NCT07535268
- Acronym / sponsor ID
- REPRESENT-PF / STUDY-25-01408
- Keywords
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Pulsed Field Ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 17 Apr 2026 (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.
This pragmatic, prospective, single-arm, multi-center, observational registry will evaluate the safety and effectiveness of PFA for the treatment of atrial fibrillation in underrepresented minority patients using FDA approved Boston Scientific PFA catheters; all data collected will be standard of care.
Detailed description
Catheter ablation is an established treatment for atrial fibrillation (AF) and is increasingly being utilized as first line therapy in patients with symptomatic AF. Pulsed field ablation (PFA) is a novel transformative technology that has demonstrated an excellent safety profile owing to its ability to achieve preferential myocardial tissue ablation and improve workflow efficiencies while exhibiting at least comparable efficacy to conventional thermal ablation modalities. This development has significant public health implications given the increasing prevalence of AF with associated morbidity and mortality.
Historically, Blacks, Hispanics, Asians and other racial and ethnic minorities have been underrepresented in clinical trials on the management of AF and specifically catheter ablation. This is further compounded by the fact that racial and ethnic minorities experience higher rates of AF-related adverse events as compared to non-minorities while being significantly less likely to receive catheter ablation therapy.
A multitude of factors have been identified as potential contributors to both the reduced utilization of catheter ablation therapy for under-represented minorities, and the increased event rates. The significant paucity of data limits more in depth analysis. It is therefore evident that greater strides towards inclusivity are needed to expand upon the clinical evidence with hopes of improving care delivery to this population.
REPRESENT-PF is a pragmatic, prospective single-arm, multi-center, observational registry studying the safety and effectiveness of PFA in underrepresented minority patients indicated for atrial arrhythmia ablation performed with Boston Scientific FDA approved catheters. The study will include both paroxysmal and persistent patients with a 1- year follow up period.
Racial or ethnic minorities will be defined based on a modified National Institutes of Health (NIH) categories: Black or African American, American Indian/Alaska native, Asian, Hawaiian or other Pacific Islander, multiracial or of Hispanic, Latino/Latina origin.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients indicated for atrial arrhythmia ablation | – | Device: FARAWAVE Pulsed Field Ablation CatheterAll patients will receive standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Racial or ethnic minorities defined based on modified National Institutes of Health (NIH) categories: Black or African American, American Indian/Alaska native, Asian, Hawaiian or other Pacific Islander, multiracial or of Hispanic, Latino/Latina origin.
Key inclusion criteria (4 listed)
- All consecutive patients classified as racial or ethnic minorities undergoing ablation using Boston Scientific FDA approved PFA catheters for AF will be included.
- De novo ablation for symptomatic paroxysmal and persistent AF (Age ≥ 18) (unless it is a repeat for a patient whose index procedure is also in the registry) who are deemed to be candidates for AF ablation by the investigator.
- Able and willing to participate in baseline and follow up evaluation over the study period
- Willing and able to provide informed consent, if applicable.
Key exclusion criteria (4 listed)
- Enrolled in an investigational drug or device clinical trial or any other trial with outlined treatment plan
- Long standing persistent AF (AF > 1 year duration)
- Repeat ablation, unless index ablation procedure was in the REPRESENT-PF registry
- Any known contra-indication to ablation procedure at the discretion of 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 |
|---|---|---|
| FARAWAVE Pulsed Field Ablation CatheterThe FARAWAVE Pulsed Field Ablation (PFA) Catheter is a component of the FARAPULSE PFA System. The FARAWAVE Catheter is an over-the-wire, multi-electrode catheter designed to deliver PFA energy to the distal section for cardiac ablation. The FARAWAVE Catheter is indicated for: 1) the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) 2) the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year) This device is FDA approved. | Device | Patients indicated for atrial arrhythmia ablation |
Primary outcome
Composite Serious Adverse Events
Time frame: up to Day 60 Post Procedure
Assess device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure The proportion of all Treatment Subjects and Attempt Subjects (combined PAF and PersAF cohort) with one or more device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure on or prior to the Day 60 Assessment, with an Onset Date following the procedure.
Chronic Treatment Success
Time frame: 12 Months
Chronic treatment success is defined as freedom from any of the following through the Day 365: * Arrhythmia: Occurrence of any detectable AF, AFL or AT * Re-ablation: Any re-ablation for AF, AFL or AT at any time following the index procedure after the blanking period. * Cardioversion: Any electrical cardioversion for AF, AFL or AT
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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Betsy Ellsworth, MSN, ANP contact
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Vivek Reddy at 2 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Devin Chamberlain ((646) 984-1049, devin.chamberlain@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Serious Adverse Events (time frame: up to Day 60 Post Procedure). 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?
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 17 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.