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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00621621
First received: February 13, 2008
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Tachycardia, Atrioventricular Nodal Reentry
Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Device or procedure related AV block persistent through discharge from hospital. [ Time Frame: After 250 subjects have been enrolled. ] [ Designated as safety issue: Yes ]

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. [ Time Frame: After 250 subjects have been enrolled. ] [ Designated as safety issue: Yes ]

Enrollment: 780
Study Start Date: December 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Focal Cryoablation Group
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
cryoablation
Other Name: 7F Freezor Cardiac CryoAblation Catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621621

Locations
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 63198-7835
United States, New York
Columbia University Medical Center and the New York Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
Principal Investigator: John Lehmann, MD, MPH Lehmann Consulting
  More Information

Publications:
Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT00621621     History of Changes
Other Study ID Numbers: PS-010
Study First Received: February 13, 2008
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Atrial Fibrillation Solutions:
atrioventricular nodal reentrant tachycardia
AVNRT

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Reciprocating

ClinicalTrials.gov processed this record on September 18, 2014