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ACTIVE NOT RECRUITING
NCT05905835
NA

Treatment of PAF With the Synaptic System

Sponsor: Synaptic Medical Corporation

View on ClinicalTrials.gov

Summary

Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure.

Official title: Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2023-09-20

Completion Date

2025-12-05

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DEVICE

Synaptic Cryoablation System

The Synaptic Cryo Balloon must be used to isolate all targeted pulmonary veins. Entrance block will be confirmed in all targeted pulmonary veins (PVs) after a 20-minute waiting period or provocative testing with adenosine or isoproterenol. Any additional ablation in the LA beside PV isolation is not allowed in this protocol. Additional ablation of the cavo-tricuspid isthmus (CTI) with a conventional market-approved RF catheter is allowed only in case a typical atrial flutter is documented in prior patient history or occurs during the case (either spontaneously or inducible).

Locations (10)

Banner University Medical Center

Phoenix, Arizona, United States

Dignity Health Arizona Research Enterprise

Phoenix, Arizona, United States

St. Bernard's Heart & Vascular

Jonesboro, Arkansas, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Mercy General Hospital

Sacramento, California, United States

St. Luke's Mid America

Kansas City, Missouri, United States

Northwell Health - Lenox Hill Hospital

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Christus Health Frances Hospital

Tyler, Texas, United States

VCU Pauley Heart Center

Richmond, Virginia, United States