CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tachycardia, Atrioventricular Nodal Reentry Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Reciprocating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freezor® Cardiac Cryoablation Catheter CryoConsole System

Device

cryoablation

Other names: 7F Freezor Cardiac CryoAblation Catheter

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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: PS-010

Important dates

Study start: 2006
Primary completion: 2013
Study completion: 2013
First posted: Feb 22, 2008
Registry last updated: Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed