CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Tachycardia, Atrioventricular Nodal Reentry Clinical Trial

— PS-010  

Official title:

CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621621
• Other study ID #: PS-010
• Status: Completed
• Phase: Phase 4
• Start date: December 2006
• Est. completion date: December 2013

Study information

• Verified date: September 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry

Intervention

Device:
• Freezor® Cardiac Cryoablation Catheter CryoConsole System
cryoablation

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Columbia University Medical Center and the New York Presbyterian Hospital	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

References & Publications (1)

Friedman PL, Dubuc M, Green MS, Jackman WM, Keane DT, Marinchak RA, Nazari J, Packer DL, Skanes A, Steinberg JS, Stevenson WG, Tchou PJ, Wilber DJ, Worley SJ. Catheter cryoablation of supraventricular tachycardia: results of the multicenter prospective "frosty" trial. Heart Rhythm. 2004 Jul;1(2):129-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device or Procedure Related AV Block Persistent Through Discharge From Hospital.		After 250 subjects have been enrolled.
Secondary	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.