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: April 6, 2015
Last verified: April 2015

February 13, 2008
April 6, 2015
December 2006
December 2013   (final data collection date for primary outcome measure)
Device or Procedure Related AV Block Persistent Through Discharge From Hospital. [ Time Frame: After 250 subjects have been enrolled. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00621621 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tachycardia, Atrioventricular Nodal Reentry
Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
cryoablation
Other Name: 7F Freezor Cardiac CryoAblation Catheter
  • 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.
    Intervention: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
  • 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.
    Intervention: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00621621
PS-010
No
Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
Principal Investigator: John Lehmann, MD, MPH Lehmann Consulting
Medtronic Atrial Fibrillation Solutions
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP