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CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
NCT00621621 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2006-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00621621
The ClinicalTrials.gov registry entry for NCT00621621 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00621621 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Minnesota, Nebraska, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00621621?
The interventions under investigation include: Freezor® Cardiac Cryoablation Catheter CryoConsole System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00621621?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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