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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
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

First Posted
February 13, 2008
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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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
No

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
No
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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