Active — Not RecruitingNot Applicable

Treatment of PAF With the Synaptic System

United States128 participantsStarted 2023-09-20

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. A physician's note indicating recurrent atrial fibrillation (AF) which includes at least two (2) symptomatic AF episodes within six (6) months prior to enrollment; AND
✓. One electrocardiographically (from any form of rhythm monitoring, including consumer devices) documented AF episode within 12 months prior to enrollment.

Exclusion criteria

✕. Left ventricular ejection fraction (LVEF) \< 40% based on most recent transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) performed ≤ 180 days prior to enrollment
✕. Left atrial diameter \> 5.5 cm or left atrial volume \> 50 ml/m2 indexed based on most recent TTE or TEE performed ≤ 180 days prior to enrollment
✕. Implanted pacemaker, ICD, CRT device within 90 days prior to enrollment
✕. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)
✕. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips
✕. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
✕. Presence of a left atrial appendage occlusion device
✕. Presence of any pulmonary vein stents

What they're measuring

safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs)

Timeframe: 6 months

Effectiveness

Timeframe: 12 months

Trial details

NCT IDNCT05905835

SponsorSynaptic Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-05

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials