# Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)

> **NCT06488820** · — · TERMINATED · sponsor: **Texas Cardiac Arrhythmia Research Foundation** · enrollment: 75 (actual)

## Conditions studied

- Atrial Fibrillation

## Interventions

- **DEVICE:** Catheter ablation using pulsed-field ablation (PFA) system

## Key facts

- **NCT ID:** NCT06488820
- **Lead sponsor:** Texas Cardiac Arrhythmia Research Foundation
- **Sponsor class:** OTHER
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** TERMINATED
- **Start date:** 2024-08-29
- **Primary completion:** 2025-04-04
- **Final completion:** 2025-04-04
- **Target enrollment:** 75 (ACTUAL)
- **Why stopped:** 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
- **Last updated:** 2025-05-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06488820

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06488820, "Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT06488820. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*