No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
275 (estimated)
Sponsor
Vivek Reddy · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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 wh…
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
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