CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Medtronic Cardiac Rhythm and Heart Failure105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Interventions

Freezor® Cardiac Cryoablation Catheter CryoConsole SystemDEVICE

cryoablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Columbia University Medical Center and the New York Presbyterian Hospital

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Device or Procedure Related AV Block Persistent Through Discharge From Hospital.

Time frame: After 250 subjects have been enrolled.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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