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NCT05905835 · ClinicalTrials.gov registry record · NA
Treatment of PAF With the Synaptic System
A NA study of Paroxysmal Atrial Fibrillation, sponsored by Synaptic Medical Corporation.
- Active
- Registry status
- NA
- Development phase
- 128
- Enrollment target
- 10
- Study locations
NCT05905835: Active NA study of Paroxysmal Atrial Fibrillation, sponsored by Synaptic Medical Corporation.
NCT05905835 is a NA study of Paroxysmal Atrial Fibrillation that is active but no longer recruiting, run by Synaptic Medical Corporation. The registered enrollment target is 128 participants, below the 854-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (85% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05905835, a NA study of Paroxysmal Atrial Fibrillation, is active but no longer recruiting, sponsored by Synaptic Medical Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
The primary endpoint for safety is an analysis of the proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs) that occur during the procedure or through the 6-month follow-up of the study. MAEs include any of the major complications as defined in the 2017 HRS expert consensus statement
Conditions Studied
Interventions
- DEVICE Synaptic Cryoablation System
Study Locations (10)
Arizona
- Banner University Medical Center - Phoenix
- Dignity Health Arizona Research Enterprise - Phoenix
California
- Cedars-Sinai Medical Center - Los Angeles
- Mercy General Hospital - Sacramento
Arkansas
- St. Bernard's Heart & Vascular - Jonesboro
Missouri
- St. Luke's Mid America - Kansas City
New York
- Northwell Health - Lenox Hill Hospital - New York
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Christus Health Frances Hospital - Tyler
Virginia
- VCU Pauley Heart Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2023-09-20 |
| Est. Completion | 2025-12-05 |
| Phase | NA |
What the registry record for NCT05905835 still lists
NCT05905835 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 854-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Synaptic Cryoablation System is the first listed.
NCT05905835 lists 10 locations in 8 states (Arizona, California, Arkansas).
Frequently Asked Questions
What is clinical trial NCT05905835 about?
NCT05905835 is a clinical study titled "Treatment of PAF With the Synaptic System". 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.
What is the current status of trial NCT05905835?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 128 participants. The study started on 2023-09-20. Estimated completion is 2025-12-05.
What conditions does trial NCT05905835 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.
What interventions are being tested in trial NCT05905835?
The interventions under investigation include: Synaptic Cryoablation System (DEVICE).
Who is sponsoring clinical trial NCT05905835?
This trial is sponsored by Synaptic Medical Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05905835 being conducted?
This trial has 10 study locations across Arizona, Arkansas, California, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05905835's enrollment target sits among peer trials
128 19th of 24 higher than 6 of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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