Paroxysmal Atrial Fibrillation: Synaptic Compliant Cryoablation Balloon and System

What is the Purpose of this Study?

The purpose of this study is to determine whether an investigational medical device called the Synaptic Cryoablation System is safe and effective for treating paroxysmal atrial fibrillation. Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart (the atria) beat very quickly and irregularly. When this happens, the atria cannot pump blood effectively. Participants will undergo an ablation procedure using the Synaptic Cryoablation System. Catheter ablation is often used to treat atrial fibrillation and involves placing catheters in the heart and delivering energy to destroy or isolate heart tissue that is thought to be responsible for the atrial fibrillation. The Synaptic Cryoablation System works by delivering energy to parts of the heart that are responsible for atrial fibrillation; it has been designed to create circular ablations using a balloon. Participants will also be asked to take a few non-invasive tests and record their heart rhythm at home.

Eligibility

* 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.

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)

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Sensation: Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation with the Synaptic Compliant Cryoablation Balloon and System.

Study Details

Disease Type/Condition

Atrial fibrillation

Principal Investigator

Shehata, Michael

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002900

ClinicalTrials.gov ID

NCT05905835

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org