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

NCT06488820 | Terminated DMC

• 1 other identifier: TCAI_SAFFICIENT
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

pulsed-field ablation

Outcome Measures

Primary Outcomes (1)

• Safety of PFA

  Adverse events

  1 year

Secondary Outcomes (1)

• Efficacy of PFA

  2-mo blanking period+ 11 months

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (1)

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Andrea Natale

  Texas Cardiac Arrhythmia Institute, St.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 11 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 5, 2024
• Study Start: August 29, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

US (1)