Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 3:38 AM
Study NCT ID:
NCT05905835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of PAF With the Synaptic System
Sponsor:
Synaptic Medical Corporation
Organization:
Study Overview
Official Title:
Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sensation
Brief 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.
Detailed Description:
A multi-center, open-label, prospective, single-arm, pre-market clinical study. 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. Data will be collected at enrollment, procedure, discharge, 1, 3, 6 and 12- months to assess the safety and effectiveness of the System. Testing for recurrence of atrial fibrillation will include a 12-lead ECG at 1, 3, 6 and 12-months post-ablation, weekly event recorder transmissions (TTM) after the 3-month follow-up visit through the 12-month follow up, and a 24-h continuous Holter ECG recording at 6 and 12-months post ablation. Symptom triggered rhythm monitoring will be used throughout the effectiveness post-ablation period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: