Treatment of PAF With the Synaptic System

NAActive, not recruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

September 20, 2023

Primary Completion Date

November 5, 2025

Study Completion Date

December 5, 2025

Conditions
Paroxysmal Atrial Fibrillation
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).

Trial Locations (10)

10075

Northwell Health - Lenox Hill Hospital, New York

23298

VCU Pauley Heart Center, Richmond

37232

Vanderbilt University Medical Center, Nashville

64111

St. Luke's Mid America, Kansas City

72401

St. Bernard's Heart & Vascular, Jonesboro

75701

Christus Health Frances Hospital, Tyler

85006

Banner University Medical Center, Phoenix

Dignity Health Arizona Research Enterprise, Phoenix

90048

Cedars-Sinai Medical Center, Los Angeles

95819

Mercy General Hospital, Sacramento

All Listed Sponsors
lead

Synaptic Medical Corporation

INDUSTRY

NCT05905835 - Treatment of PAF With the Synaptic System | Biotech Hunter | Biotech Hunter