Treatment of PAF With the Synaptic System

Paroxysmal Atrial Fibrillation Clinical Trial

— Sensation  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905835
• Other study ID #: CS-0001
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Synaptic Medical Corporation
• Contact: Meital Mazor
• Phone: 760-608-8388
• Email: meital.mazor[@]synapticmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• 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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Synaptic Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 following major complications as defined in the 2017 HRS expert consensus statement	6 months
Primary	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	Safety - Change from baseline NIH Stroke Scale post-ablation	Change from baseline NIH Stroke Scale post-ablation	Day 1
Secondary	Safety - Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)	Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)	7 days
Secondary	Safety - Incidence of late onset (>7 days) of SAEs	Incidence of late onset (>7 days) of SAEs	12 months
Secondary	Effectiveness - Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins	Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins	Day 0
Secondary	Effectiveness - Rate of pulmonary vein isolation on a per-vein basis	• Rate of pulmonary vein isolation on a per-vein basis	Day 0
Secondary	Effectiveness - Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period	Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period	12 months
Secondary	Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period	Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period	12 months
Secondary	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	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	12 months
Secondary	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	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	6 months
Secondary	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	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	Day 0
Secondary	Performance - Procedure time, defined as the time elapsed from first venous access to last sheath removal	Procedure time, defined as the time elapsed from first venous access to last sheath removal	Day 0
Secondary	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	Duration of LA dwell time, defined as time from the Cryo Balloon Catheter exiting the sheath in the LA to time of final PVI	Day 0
Secondary	Performance - Total cryoablation time for index procedure	Total cryoablation time for index procedure	Day 0
Secondary	Performance - Total fluoroscopy time for index procedure	Total fluoroscopy time for index procedure	Day 0
Secondary	Performance - Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery	Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery	Day 0
Secondary	Performance -Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up	Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up	12 months