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| Sponsored by: |
CryoCath Technologies Inc. |
|---|---|
| Information provided by: | CryoCath Technologies Inc. |
| ClinicalTrials.gov Identifier: | NCT00621621 |
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: 7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) |
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
The safety and effectiveness of cryoablation using CryoCath Technologies, Inc. Freezor™ Cardiac Cryoablation Catheter and CCT.2 CryoConsole System in the treatment of atrioventricular nodal reentrant tachycardia (AVNRT) was demonstrated in the FROSTY clinical investigation (P020045).
This clinical study demonstrated that intent-to-treat AVNRT subjects had a 91% acute procedural success rate and a long term clinical success rate at 6 months of follow up (conditional on acute procedural success) of 94%. There were no recurrences after 3 months. Eleven (11%) subjects had transient AV block that resolved—generally immediately—without further intervention. No FROSTY subject with AVNRT (0 of 103; 0% with 95%CI 0 - 3.5%) had permanent heart block or required the implantation of a permanent pacemaker.
A condition of approval stipulated by the Circulatory Systems Device Panel was "post-market surveillance for heart block as a measure of safety of the procedure".1 The Panel clarified that it was not requesting proof that the incidence of heart block resulting from cryoablation for AVNRT was better than RF, but that "the intent of the condition is to identify an unusually large number of AV blocks, an unanticipated number of AV blocks".2 Proposed performance levels for this study included "add a certain delta to that 1 percent level … at 3, 4, 5 percent",3 "2 percent",4 "3 percent".5
In a similar study resulting in the approval of the Atakr device, 5 of 373 AVNRT subjects (1.3% with 95%CI 0 - 3.1%).6
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
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:
Contacts and Locations| Contact: David Castelo | 514-694-2380 ext 252 | dcastelo@cryocath.com |
| Contact: Patrick Chauvet | 514-694-2380 ext 287 | pchauvet@cryocath.com |
| United States, Minnesota | |
| Minneapolis Heart Institute Foundation | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Karen S. Meyer, RN, BSN, CCRC 612-863-5855 Karen.Meyer2@allina.com | |
| Principal Investigator: William Katsiyiannis, M.D. | |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 63198-7835 | |
| Contact: Carol A. Henrich, RN 402-203-9800 chenrich@unmc.edu | |
| Principal Investigator: Mark J. Niebauer, M.D., Ph.D | |
| United States, New York | |
| Columbia University Medical Center and the New York Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Kathleen Hickey, C-FNP, C-ANP, Ed.D. 212-305-0897 kth6@columbia.edu | |
| Principal Investigator: Hasan Garan, M.D. | |
| Principal Investigator: | John Lehmann, MD, MPH | Lehmann Consulting |
More Information
| Responsible Party: | CryoCath Technologies Inc. ( David Castelo, Manager, Clinical Projects ) |
| Study ID Numbers: | PS-010 |
| Study First Received: | February 13, 2008 |
| Last Updated: | February 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00621621 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
atrioventricular nodal reentrant tachycardia AVNRT |
|
Heart Diseases Tachycardia Tachycardia, Atrioventricular Nodal Reentry Arrhythmias, Cardiac |
|
Pathologic Processes Heart Diseases Tachycardia Cardiovascular Diseases |
Tachycardia, Reciprocating Tachycardia, Atrioventricular Nodal Reentry Arrhythmias, Cardiac |
