Treatment for Paroxysmal Atrial Fibrillation using Cryoablation

Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System

This study is testing a new cryoablation treatment for people with Paroxysmal Atrial Fibrillation to see if it can help reduce their symptoms and prevent the condition from coming back.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 185 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Synaptic Medical Corporation (Industry-sponsored)
• Locations: 9 sites (Phoenix, Arizona and 8 other locations)
• Trial ID: NCT05905835 on ClinicalTrials.gov

What this trial studies

This clinical trial involves the treatment of patients with symptomatic Paroxysmal Atrial Fibrillation (PAF) using the Synaptic Cryoablation System. Participants will undergo cryoablation of the pulmonary veins to achieve pulmonary vein isolation (PVI). The study is multi-center and open-label, with a follow-up period of twelve months to assess safety and effectiveness. Data will be collected at various intervals post-ablation to monitor for recurrence of atrial fibrillation and evaluate patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with symptomatic PAF who are refractory or intolerant to at least one anti-arrhythmic medication.

Not a fit: Patients who do not have symptomatic PAF or are not suitable candidates for catheter ablation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of atrial fibrillation episodes in patients suffering from PAF.

How similar studies have performed: Previous studies using cryoablation for atrial fibrillation have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. 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
  2. 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.

Exclusion Criteria:

* 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:

  1. Left ventricular ejection fraction (LVEF) \< 40% based on most recent transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) performed ≤ 180 days prior to enrollment
  2. 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
  3. Implanted pacemaker, ICD, CRT device within 90 days prior to enrollment
  4. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)
  5. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips
  6. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
  7. Presence of a left atrial appendage occlusion device
  8. Presence of any pulmonary vein stents
  9. Coronary artery bypass graft (CABG), PTCA, PCI, or coronary stent procedures within 90 days prior to enrollment
  10. Unstable angina or ongoing myocardial ischemia
  11. ST-Elevation Myocardial Infarction (STEMI) within 90 days prior to enrollment
  12. Moderate or Severe Mitral Insufficiency or Mitral Stenosis, severity based on the most recent TTE or TEE performed ≤ 180 days prior to enrollment
  13. 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
* Pregnant or lactating (current or anticipated during the study)
* Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
* Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes, but not limited to, vulnerable patient population, mental illness, Gastroesophageal Reflux Disease (GERD), addictive disease, terminal illness with a life expectancy of less than two (2) years, or extensive travel away from the research center)

Where this trial is running

Phoenix, Arizona and 8 other locations

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

Study contacts

• Study coordinator: Meital Mazor

Conditions Paroxysmal Atrial Fibrillation