Treatment of PAF With the Synaptic System

Running, not enrolling · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05905835

Run by

Synaptic Medical Corporation

People needed

128

Starts

2023-09-20

Expected to finish

2025-12-05

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either through procedure or drug therapy) within seven (7) days of onset. Minimum documentation includes the following:
• 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.
• Refractory or intolerant to at least one (1) Class I or III anti-arrhythmic medication or contraindicated to any class I or III medication.
• Suitable candidate for catheter ablation.
• Adults aged 18 - 80 years.
• Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
• Willing and able to provide informed consent.

You may not qualify if…

• Diagnosis of persistent AF, i.e., continuous AF lasting longer than seven (7) days from onset
• In the opinion of the Investigator, any known contraindication to an atrial ablation or anticoagulation. Including but not limited to the identification of any atrial thrombus or evidence of sepsis
• History of previous left atrial ablation or surgical treatment for AF/AFL/AT
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
• Body Mass Index (BMI) ≥ 40
• Structural heart disease or implanted devices as described below:
• 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
• Coronary artery bypass graft (CABG), PTCA, PCI, or coronary stent procedures within 90 days prior to enrollment
• Unstable angina or ongoing myocardial ischemia
• ST-Elevation Myocardial Infarction (STEMI) within 90 days prior to enrollment
• Moderate or Severe Mitral Insufficiency or Mitral Stenosis, severity based on the most recent TTE or TEE performed ≤ 180 days prior to enrollment
• Evidence of left atrial thrombus
• History of cryoglobulinemia
• Significant untreated restrictive or obstructive pulmonary disease or chronic respiratory condition
• Renal failure requiring dialysis
• History of blood clotting or bleeding disease
• History of documented cerebral infarct, TIA or systemic embolism,excluding post-operative deep vein thrombosis (DVT) ≤ 180 days prior to enrollment
• Active systemic infection

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States
• Dignity Health Arizona Research Enterprise — Phoenix, Arizona, United States
• St. Bernard's Heart & Vascular — Jonesboro, Arkansas, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Mercy General Hospital — Sacramento, California, United States
• St. Luke's Mid America — Kansas City, Missouri, United States
• Northwell Health - Lenox Hill Hospital — New York, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Christus Health Frances Hospital — Tyler, Texas, United States
• VCU Pauley Heart Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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