CONVERGE Post-Approval Study (PAS)

Condition(s) studied

Investigational drug(s) / intervention(s)

Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF: Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. This will be done endocardially using an irrigated endocardial ablation catheter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation. .

Study summary

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Eligibility

Primary outcome measure(s)

• Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD. — 1 year
  Primary Effectiveness Endpoint: The primary effectiveness endpoint is defined as the number of participants that exhibit freedom from AF/AT/AFL absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 90-day blanking period through the 12-months post procedure follow-up visit. The primary effectiveness endpoint will be evaluated based on the first 24 hours of the 7-days Holter monitoring. Participants will be considered failures if any of the following conditions are observed: AF/AFL/AT greater than 30 seconds, new or increased dose of previously failed AAD through 12 month post procedure visit, Cardioversion through 12 months post procedure, left sided catheter ablation through 12 months post procedure and catheter ablation for right sided typical atrial flutter. Failures will be compared to total cohort to establish a success rate.
• Primary Safety Endpoint, Incidence of defined Major Adverse Events — 30-days post procedure
  The primary safety endpoint for the study is defined as the number of participants that exhibit device or procedure-related major adverse events (MAEs) for subjects undergoing the Hybrid Convergent procedure from the index procedure through 30-days post procedure. Participants will be considered failures if the following is exhibted: * Pericardial effusions with cardiac tamponade defined as effusions resulting in hemodynamic compromise. * Severe pulmonary vein (PV) stenosis * Excessive bleeding requiring reoperation * Myocardial infarction (MI); * Stroke, transient ischemic attacks (TIA); * Atrioesophageal fistula (AEF) through 3-months post-procedure; * Phrenic nerve injury * Death Failures will be compared to total cohort of participants to establish success rate.

Trial sites (13)

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