Clinical trial NCT05905835: Treatment of PAF With the Synaptic System
Official title: Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Synaptic Medical Corporation
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: A multi-center, open-label, prospective, single-arm, pre-market clinical study. 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. Data will be collected at enrollment, procedure, discharge, 1, 3, 6 and 12- months to assess the safety and effectiveness of the System. Testing for recurrence of atrial fibrillation will include a 12-lead ECG at 1, 3, 6 and 12-months post-ablation, weekly event recorder transmissions after the 3- month follow-up visit through the 12-month follow up, and a 24-h continuous Holter ECG recording at 6 and 12-months post ablation. Symptom triggered rhythm monitoring will be used throughout the effectiveness post-ablation period.

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)

Primary outcomes:
measure: safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs)
timeFrame: 6 months
measure: Effectiveness
timeFrame: 12 months
Secondary outcomes:
measure: Safety - Change from baseline NIH Stroke Scale post-ablation
timeFrame: Day 1
measure: Safety - Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
timeFrame: 7 days
measure: Safety - Incidence of late onset (>7 days) of SAEs
timeFrame: 12 months
measure: Effectiveness - Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
timeFrame: Day 0
measure: Effectiveness - Rate of pulmonary vein isolation on a per-vein basis
timeFrame: Day 0
measure: Effectiveness - Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
timeFrame: 12 months
measure: Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period
timeFrame: 12 months
measure: Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
timeFrame: 12 months
measure: Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
timeFrame: 6 months
measure: Performance - Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
timeFrame: Day 0
measure: Performance - Procedure time, defined as the time elapsed from first venous access to last sheath removal
timeFrame: Day 0
measure: Performance - Duration of LA dwell time, defined as time from the Cryo Balloon Catheter exiting the sheath in the LA to time of final PVI
timeFrame: Day 0
measure: Performance - Total cryoablation time for index procedure
timeFrame: Day 0
measure: Performance - Total fluoroscopy time for index procedure
timeFrame: Day 0
measure: Performance - Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery
timeFrame: Day 0
measure: Performance -Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernard's Heart & Vascular
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Kansas City
country: United States
facility: St. Luke's Mid America
state: Missouri
city: New York
country: United States
facility: Northwell Health - Lenox Hill Hospital
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Tyler
country: United States
facility: Christus Health Frances Hospital
state: Texas
city: Richmond
country: United States
facility: VCU Pauley Heart Center
state: Virginia
Study officials:
References: