ACTIVE_NOT_RECRUITING

Treatment of PAF With the Synaptic System

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-20

Study Completion:2025-11-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05905835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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)

Inclusion Criteria

Exclusion 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.

* 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)

Contacts and Locations

Study Locations (Sites)

Banner University Medical Center

Phoenix, Arizona, 85006

United States

Dignity Health Arizona Research Enterprise

Phoenix, Arizona, 85006

United States

St. Bernard's Heart & Vascular

Jonesboro, Arkansas, 72401

United States

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Mercy General Hospital

Sacramento, California, 95819

United States

St. Luke's Mid America

Kansas City, Missouri, 64111

United States

Northwell Health - Lenox Hill Hospital

New York, New York, 10075

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Christus Health Frances Hospital

Tyler, Texas, 75701

United States

VCU Pauley Heart Center

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Synaptic Medical Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-20

Study Completion Date2025-11-05

Study Record Updates

Study Start Date2023-09-20

Study Completion Date2025-11-05

Terms related to this study

Additional Relevant MeSH Terms

Paroxysmal Atrial Fibrillation