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CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) (PS-010)

Primary Purpose

Tachycardia, Atrioventricular Nodal Reentry

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Freezor® Cardiac Cryoablation Catheter CryoConsole System

About this trial

This is an interventional treatment trial for Tachycardia, Atrioventricular Nodal Reentry focused on measuring atrioventricular nodal reentrant tachycardia, AVNRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Minneapolis Heart Institute Foundation
University of Nebraska Medical Center
Columbia University Medical Center and the New York Presbyterian Hospital
Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Freezor Catheter for AVNRT

External Data Supporting the Study

Arm Description

Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.

This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.

Outcomes

Primary Outcome Measures

Device or Procedure Related AV Block Persistent Through Discharge From Hospital.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00621621

First Posted

February 13, 2008

Last Updated

September 17, 2018

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT00621621

Brief Title

CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Acronym

PS-010

Official Title

CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tachycardia, Atrioventricular Nodal Reentry

Keywords

atrioventricular nodal reentrant tachycardia, AVNRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Freezor Catheter for AVNRT

Arm Type

Experimental

Arm Description

Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.

Arm Title

External Data Supporting the Study

Arm Type

Other

Arm Description

This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.

Intervention Type

Device

Intervention Name(s)

Freezor® Cardiac Cryoablation Catheter CryoConsole System

Other Intervention Name(s)

7F Freezor Cardiac CryoAblation Catheter

Intervention Description

cryoablation

Primary Outcome Measure Information:

Title

Device or Procedure Related AV Block Persistent Through Discharge From Hospital.

Time Frame

After 250 subjects have been enrolled.

Secondary Outcome Measure Information:

Title

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.

Time Frame

After 250 subjects have been enrolled.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Lehmann, MD, MPH

Organizational Affiliation

Lehmann Consulting

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minneapolis Heart Institute Foundation

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

63198-7835

Country

United States

Facility Name

Columbia University Medical Center and the New York Presbyterian Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15851143

Citation

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. doi: 10.1016/j.hrthm.2004.02.022.

Results Reference

background

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CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

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