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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Tachycardia, Atrioventricular Nodal Reentry

Treatments: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621621

PS-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Freezor Catheter for AVNRT

Experimental group

Description:

Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.

Treatment:

Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System

External Data Supporting the Study

Other group

Description:

This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.

Treatment:

Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System