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:
  • 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.
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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?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Atrial fibrillation

Principal Investigator

Shehata, Michael

Age Group

Adult

Phase

N/A

IRB Number

CS-0001

ClinicalTrials.gov ID

NCT05905835

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org