CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) (PS-010)
This study is currently recruiting participants.
Verified February 2013 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00621621
First received: February 13, 2008
Last updated: February 12, 2013
Last verified: February 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 13, 2008 | ||||||||
| Last Updated Date | February 12, 2013 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Device or procedure related AV block persistent through discharge from hospital. [ Time Frame: After 250 subjects have been enrolled. ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00621621 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) | ||||||||
| Official Title ICMJE | CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Tachycardia, Atrioventricular Nodal Reentry | ||||||||
| Intervention ICMJE | Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
cryoablation
Other Name: 7F Freezor Cardiac CryoAblation Catheter |
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| Study Arm (s) | 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.
Intervention: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00621621 | ||||||||
| Other Study ID Numbers ICMJE | PS-010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Medtronic Atrial Fibrillation Solutions | ||||||||
| Study Sponsor ICMJE | Medtronic Atrial Fibrillation Solutions | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medtronic Atrial Fibrillation Solutions | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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