CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Study Overview
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Brief Summary
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The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.

Detailed Description
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Due to the lack of enrollments for the trial. The FDA and Medtronic discussed the inclusion of data found from from published literature (external studies) to corroborate study endpoint. The FDA allowed this data and the study was closed.

Official Title
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CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Conditions
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Tachycardia, Atrioventricular Nodal Reentry

Intervention / Treatment
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* Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria. For inclusion in the study subjects must fulfill ALL of the following criteria: Pre-EPS inclusion criteria: Patients with a clinical history of AVNRT who are referred for ablation. Patients willing to provide written informed consent. Post-EPS inclusion criteria: 1. Patients with EPS-documented AVNRT Exclusion Criteria: ANY of the following is regarded as a criterion for excluding a subject from the study: Patients with any pre-existing AV block. Patients with known cryoglobulinemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freezor Catheter for AVNRT<br>Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia. | Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System<br>* cryoablation<br>* Other names: 7F Freezor Cardiac CryoAblation Catheter;|
| Other: External Data Supporting the Study<br>This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT. | Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System<br>* cryoablation<br>* Other names: 7F Freezor Cardiac CryoAblation Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device or Procedure Related AV Block Persistent Through Discharge From Hospital. |  | After 250 subjects have been enrolled. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up. |  | After 250 subjects have been enrolled. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrioventricular nodal reentrant tachycardia, AVNRT