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

NCT06488820 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2025-05-28

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Catheter ablation using pulsed-field ablation (PFA) system

PFA will be used to isolate the pulmonary veins and additional left atrial structure as needed

Sponsors & Collaborators

  • Texas Cardiac Arrhythmia Research Foundation

    lead OTHER

Principal Investigators

  • Andrea Natale · Texas Cardiac Arrhythmia Institute, St.

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-29
Primary Completion
2025-04-04
Completion
2025-04-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06488820 on ClinicalTrials.gov