CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Phase 4

Completed

• Conditions: Tachycardia, Atrioventricular Nodal Reentry
• Interventions: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System

• Registration Number: NCT00621621
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-07-22
• Results First Submitted QC: 2015-04-06
• Results First Posted: 2015-04-23
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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:

1. Patients with a clinical history of AVNRT who are referred for ablation.
2. 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:

1. Patients with any pre-existing AV block.
2. Patients with known cryoglobulinemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
External Data Supporting the Study	Freezor® Cardiac Cryoablation Catheter CryoConsole System	This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
Freezor Catheter for AVNRT	Freezor® Cardiac Cryoablation Catheter CryoConsole System	Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.

Primary Outcome Measures

Name	Time	Method
Device or Procedure Related AV Block Persistent Through Discharge From Hospital.	After 250 subjects have been enrolled.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Columbia University Medical Center and the New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States