Active, not recruiting
Not applicable
Treatment of PAF With the Synaptic System
Condition(s) studied
Paroxysmal Atrial Fibrillation
Investigational drug(s) / intervention(s)
Synaptic Cryoablation System
Synaptic Cryoablation System: The Synaptic Cryo Balloon must be used to isolate all targeted pulmonary veins. Entrance block will be confirmed in all targeted pulmonary veins (PVs) after a 20-minute waiting period or provocative testing with adenosine or isoproterenol. Any additional ablation in the LA beside PV isolation is not allowed in this protocol. Additional ablation of the cavo-tricuspid isthmus (CTI) with a conventional market-approved RF catheter is allowed only in case a typical atrial flutter is documented in prior patient history or occurs during the case (either spontaneously or inducible).
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.
Eligibility
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)
Primary outcome measure(s)
- safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs) — 6 months
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
- Effectiveness — 12 months
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90- day blanking period.
Trial sites (10)
| Facility | City | Region | Status |
| Banner University Medical Center |
Phoenix |
Arizona |
|
| Dignity Health Arizona Research Enterprise |
Phoenix |
Arizona |
|
| St. Bernard's Heart & Vascular |
Jonesboro |
Arkansas |
|
| Cedars-Sinai Medical Center |
Los Angeles |
California |
|
| Mercy General Hospital |
Sacramento |
California |
|
| St. Luke's Mid America |
Kansas City |
Missouri |
|
| Northwell Health - Lenox Hill Hospital |
New York |
New York |
|
| Vanderbilt University Medical Center |
Nashville |
Tennessee |
|
| Christus Health Frances Hospital |
Tyler |
Texas |
|
| VCU Pauley Heart Center |
Richmond |
Virginia |
|