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NCT00621621 · ClinicalTrials.gov registry record · Phase 4

CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

A Phase 4 study of Tachycardia, Atrioventricular Nodal Reentry, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

Completed
Registry status
Phase 4
Development phase
105
Enrollment target
4
Study locations

NCT00621621: Completed Phase 4 study of Tachycardia, Atrioventricular Nodal Reentry, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

NCT00621621 is a Phase 4 study of Tachycardia, Atrioventricular Nodal Reentry that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 105 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00621621, a Phase 4 study of Tachycardia, Atrioventricular Nodal Reentry, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

COMPLETED
Registry status
Phase 4
Development phase
105 participants
Enrollment target
4
Study locations

Study 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.

Interventions

  • DEVICE Freezor® Cardiac Cryoablation Catheter CryoConsole System

Study Locations (4)

Minnesota

  • Minneapolis Heart Institute Foundation - Minneapolis

Nebraska

  • University of Nebraska Medical Center - Omaha

New York

  • Columbia University Medical Center and the New York Presbyterian Hospital - New York

Ohio

  • Cleveland Clinic Foundation - Cleveland

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2006-12
Est. Completion 2013-12
Phase Phase 4

What the finished NCT00621621 record still lists

NCT00621621 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Tachycardia, Atrioventricular Nodal Reentry appearing as the primary indexed condition, and to 1 intervention - of which Freezor® Cardiac Cryoablation Catheter CryoConsole System is the first listed.

NCT00621621 reports a single indexed study location in Minnesota, Nebraska, New York.

Frequently Asked Questions

What is clinical trial NCT00621621 about?

NCT00621621 is a clinical study titled "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.

What is the current status of trial NCT00621621?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2006-12. Estimated completion is 2013-12.

What conditions does trial NCT00621621 study?

This clinical trial studies the following conditions: Tachycardia, Atrioventricular Nodal Reentry.

What interventions are being tested in trial NCT00621621?

The interventions under investigation include: Freezor® Cardiac Cryoablation Catheter CryoConsole System (DEVICE).

Who is sponsoring clinical trial NCT00621621?

This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00621621 being conducted?

This trial has 4 study locations across Minnesota, Nebraska, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00621621's enrollment target sits among peer trials

105 749th of 2000 higher than 1,248 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00621621, the US trial registry maintained by the National Library of Medicine. NCT00621621 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.