| NCT ID | NCT07535268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vivek Reddy |
| Condition | Persistent Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 275 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 275 participants in total. It began in 2026-03-30 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Vivek Reddy, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07535268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07535268 currently recruiting?
Yes, NCT07535268 is actively recruiting participants. Contact the research team at devin.chamberlain@mountsinai.org for enrollment information.
Where is the NCT07535268 trial being conducted?
This trial is being conducted at New York, United States, Winchester, United States.
Who is sponsoring the NCT07535268 clinical trial?
NCT07535268 is sponsored by Vivek Reddy. The principal investigator is Vivek Reddy, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 275 participants.
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