N/A
Completed N=1,071
Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
Source: ClinicalTrials.gov NCT02433613 ↗Enrolled (actual)
1,071
Serious AEs
3.9%
Results posted
May 2020
Primary outcomePrimary: Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate — 185.1 Days
Summary
Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance.
Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate |
185.1 | — |
| SECONDARY Estimate Phased RFA Mid-term Safety |
27 | — |
Eligibility Criteria
Inclusion criteria
- Patient with AF who is scheduled for Phased RFA procedure
- Patient signed patient informed consent or patient data release form
- Age ≥18 years old To avoid enrollment bias in this cohort of patient and reflect "real world" clinical practice for Phased RFA no exclusion criteria will be defined.
Data sourced from ClinicalTrials.gov (NCT02433613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.