REPRESENT-PF Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVivek Reddy
About this trial
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
Qualifiers
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.
Disqualifiers
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 design
Treatments tested in this trial
- FARAWAVE Pulsed Field Ablation Catheter
Treatment groups
275 Participants
are divided into 1 treatment groupSponsors and collaborators
Vivek Reddy
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov