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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00621621
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : April 23, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
Study Start Date : December 2006
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Freezor Catheter for AVNRT
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
External Data Supporting the Study
This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
 Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
cryoablation
Other Name: 7F Freezor Cardiac CryoAblation Catheter


Outcome Measures
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Primary Outcome Measures :
  1. Device or Procedure Related AV Block Persistent Through Discharge From Hospital. [ Time Frame: After 250 subjects have been enrolled. ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621621


Locations
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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 Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: John Lehmann, MD, MPH Lehmann Consulting
More Information
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Publications:

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00621621    
Other Study ID Numbers: PS-010
First Posted: February 22, 2008    Key Record Dates
Results First Posted: April 23, 2015
Last Update Posted: October 16, 2018
Last Verified: September 2018
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
atrioventricular nodal reentrant tachycardia
AVNRT
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Tachycardia, Reciprocating