Treatment of PAF With the Synaptic System

NCT05905835 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CS-0001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 10

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

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

  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

  6 months

• Effectiveness

  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.

  12 months

Secondary Outcomes (16)

• Safety - Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)

  7 days

• Safety - Incidence of late onset (>7 days) of SAEs

  12 months

• Safety - Change from baseline NIH Stroke Scale post-ablation

  Day 1

• Effectiveness - Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins

  Day 0

• Effectiveness - Rate of pulmonary vein isolation on a per-vein basis

  Day 0

Study Arms (1)

Cryoablation Balloon

EXPERIMENTAL

The Synaptic Cryo Balloon will be used to isolate all targeted pulmonary veins.

Device: Synaptic Cryoablation System

Interventions

Synaptic Cryoablation System DEVICE

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).

Cryoablation Balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Synaptic Medical Corporation: lead

Study Sites (10)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Dignity Health Arizona Research Enterprise

Phoenix, Arizona, 85006, United States

Location

St. Bernard's Heart & Vascular

Jonesboro, Arkansas, 72401, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

St. Luke's Mid America

Kansas City, Missouri, 64111, United States

Location

Northwell Health - Lenox Hill Hospital

New York, New York, 10075, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Christus Health Frances Hospital

Tyler, Texas, 75701, United States

Location

VCU Pauley Heart Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 15, 2023
• Study Start: September 20, 2023
• Primary Completion: November 5, 2025
• Study Completion: December 5, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)