MedTrace Logo

Treatment of PAF With the Synaptic System

NCT05905835 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-09-11

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Synaptic Medical Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-11-05
Completion
2025-12-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05905835 on ClinicalTrials.gov