Phase 4
Completed N=810
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
Tachycardia, Atrioventricular Nodal Reentry
Source: ClinicalTrials.gov NCT00621621 ↗
Enrolled (actual)
810
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Device or Procedure Related AV Block Persistent Through Discharge From Hospital. — 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device or Procedure Related AV Block Persistent Through Discharge From Hospital. |
0; 0 | — |
| SECONDARY 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. |
0; 0 | — |
Eligibility 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:
- Patients with a clinical history of AVNRT who are referred for ablation.
- Patients willing to provide written informed consent.
Post-EPS inclusion criteria:
- Patients with EPS-documented AVNRT
Exclusion Criteria
ANY of the following is regarded as a criterion for excluding a subject from the study:
- Patients with any pre-existing AV block.
- Patients with known cryoglobulinemia
Data sourced from ClinicalTrials.gov (NCT00621621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.