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NCT06488820 · ClinicalTrials.gov registry record
Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)
A clinical trial, sponsored by Texas Cardiac Arrhythmia Research Foundation.
- Terminated
- Registry status
- 75
- Enrollment target
NCT06488820 is a clinical trial that was terminated before completion, run by Texas Cardiac Arrhythmia Research Foundation. The registered enrollment target is 75 participants.
The verdict
NCT06488820 was terminated before completion, sponsored by Texas Cardiac Arrhythmia Research Foundation.
- TERMINATED
- Registry status
- 75 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Catheter ablation using pulsed-field ablation (PFA) system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2025-04-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06488820
The ClinicalTrials.gov registry entry for NCT06488820 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Cardiac Arrhythmia Research Foundation, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Catheter ablation using pulsed-field ablation (PFA) system is the first listed.
NCT06488820 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06488820 about?
NCT06488820 is a clinical study titled "Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)". 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 proce...
What is the current status of trial NCT06488820?
This trial is currently terminated. The enrollment target is 75 participants. The study started on 2024-08-29. Estimated completion is 2025-04-04.
What interventions are being tested in trial NCT06488820?
The interventions under investigation include: Catheter ablation using pulsed-field ablation (PFA) system (DEVICE).
Who is sponsoring clinical trial NCT06488820?
This trial is sponsored by Texas Cardiac Arrhythmia Research Foundation, which has 15 total clinical trials registered on ClinicalTrials.gov.
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