CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Tachycardia, Atrioventricular Nodal Reentry

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Freezor® Cardiac Cryoablation Catheter CryoConsole System

Intervention Type DEVICE

cryoablation

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.

Group Type OTHER

Freezor® Cardiac Cryoablation Catheter CryoConsole System

Intervention Type DEVICE

cryoablation

Interventions

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Freezor® Cardiac Cryoablation Catheter CryoConsole System

cryoablation

Intervention Type DEVICE

Other Intervention Names

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7F Freezor Cardiac CryoAblation Catheter

Eligibility Criteria

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Inclusion Criteria

For inclusion in the study subjects must fulfill ALL of the following criteria:

1. Patients with a clinical history of AVNRT who are referred for ablation.
2. Patients willing to provide written informed consent.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No