REPRESENT-PF Registry
Recruiting · NCT07535268 · Observational (researchers observe without assigning treatment) · Lead sponsor: Vivek Reddy
View the official record on ClinicalTrials.gov →Interventions studied
FARAWAVE Pulsed Field Ablation Catheter
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed across 2 US states.
- The Mount Sinai Hospital - New York, New York, United States
- Valley Health System - Winchester, Virginia, United States