Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)
Megadott ok: Given the recent FDA approval of the VARIPULSE platform in November 2024, J\&J MedTech and the PI have made the strategic decision to phase out SAFFICIENT IDE to focus on the post-approval study
Key facts
- Where
- Austin, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- Texas Cardiac ArrhythmiaAustin, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Texas Cardiac Arrhythmia Research Foundation
- Trial code
- NCT06488820
- Record updated
- 2025. május 28.
- Original description
Catheter ablation using radiofrequency (RF) energy has been widely adopted for management of atrial fibrillation (AF) for the past several years.Read full original descriptionShow less
Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers
Catheter ablation using radiofrequency (RF) energy has been widely adopted for management of atrial fibrillation (AF) for the past several years.
However, heterogeneity of outcomes and complication rates are still reported that have been partly attributed to operator's experience and center's procedure volume (1). In a meta-analysis of 14 studies, both hospital volume of ≥50 and ≥100 procedures per year were associated with significantly lower complication rate compared to <50/year (2).
Pulse-field ablation (PFA) is an emerging technology for AF management that has demonstrated tremendous potential in terms of preferential tissue ablation with no damage to the adjacent organs. In the MANIFEST-PF survey, 24 European centers participated that had a mean of 704 ablations per year with 73.3 (range 7-291) PFA ablations annually (3). No post-PFA esophageal complications, PV stenosis or persistent phrenic nerve injury were reported. There appeared to be a trend toward fewer complications with center experience, particularly for pericardial tamponade (3).
However, the impact of number of PFA performed on procedure-success and safety has not been evaluated in the US.
This multicenter prospective study is designed to compare the incidence of adverse event (AE) and long-term procedural success of pulse-field ablation for AF in low volume (<100/year) vs. high volume (≥100/year) centers.
Inclusion: Age: >≥18 years; Symptomatic Paroxysmal or Persistent AF patients of ≤ 1 year; First ablation or redo procedure to treat AF; Willing to provide written informed consent; Able and willing to comply with all testing and requirements.
Exclusion: Long-standing persistent AF Page 17 of 70; Any condition contraindicating chronic anticoagulation; Prosthetic mechanical valves; Recent MI (in <3 months); Active systemic infection; Pregnant or lactating women; Current enrollment in an investigational study evaluating another device or drug; Documented left atrial (LA) thrombus by imaging within 48 hours before procedure (computed tomography (CT), transesophageal echocardiogram (TEE), or intracardiac echocardiogram (ICE) at the beginning of the procedure); Uncontrolled heart failure or New York Heart Association (NYHA) Class IV; Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study; Life expectancy less than 12 months.