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NCT00630916 · ClinicalTrials.gov registry record · NA
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
A NA study of Heart Valve Diseases, sponsored by Sorin Group USA.
- Completed
- Registry status
- NA
- Development phase
- 756
- Enrollment target
- 20
- Study locations
NCT00630916: Completed NA study of Heart Valve Diseases, sponsored by Sorin Group USA.
NCT00630916 is a NA study of Heart Valve Diseases that has completed, run by Sorin Group USA. The registered enrollment target is 756 participants, below the 1,027-participant average among 13 other Heart Valve Diseases trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00630916, a NA study of Heart Valve Diseases, has completed, sponsored by Sorin Group USA.
- COMPLETED
- Registry status
- NA
- Development phase
- 756 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Primary Outcome
Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring \>30 days after valve implant.
Conditions Studied
Interventions
- DEVICE Mitroflow Aortic Heart Valve
Study Locations (20)
Pennsylvania
- Hershey Medical Center - Hershey
- Hospital of the Univ. of PA - Philadelphia
- Lankenau Hospital - Wynnewood
Texas
- Baylor Univ. Medical Center - Dallas
- Denton Regional Medical - Denton
- Medical Center of Plano - Plano
Arizona
- Banner Good Samaritan - Phoenix
- The University of Arizona - Tucson
Indiana
- Methodist Hospital - Indianapolis
- Heart Center of Indiana - Indianapolis
Maryland
- Johns Hopkins Hospital - Baltimore
- St. Joseph's Medical Center - Towson
New Jersey
- Saint Michael's Med. Center - Newark
- Newark Beth Israel Med Ctr - Newark
California
- Sharp Memorial Hospital - San Diego
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 756 participants |
| Start Date | 2003-11 |
| Est. Completion | 2007-12 |
| Phase | NA |
What the finished NCT00630916 record still lists
NCT00630916 is an interventional study that assigns participants to a tested intervention. The registered 756 participants enrollment target is mid-sized for trials with a published cap, below the 1,027-participant average among 13 other Heart Valve Diseases trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Heart Valve Diseases appearing as the primary indexed condition, and to 1 intervention - of which Mitroflow Aortic Heart Valve is the first listed.
NCT00630916 names 20 study sites across 12 states, led by Pennsylvania, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT00630916 about?
NCT00630916 is a clinical study titled "Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve". This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
What is the current status of trial NCT00630916?
This trial is currently completed. It is a NA study. The enrollment target is 756 participants. The study started on 2003-11. Estimated completion is 2007-12.
What conditions does trial NCT00630916 study?
This clinical trial studies the following conditions: Heart Valve Diseases.
What interventions are being tested in trial NCT00630916?
The interventions under investigation include: Mitroflow Aortic Heart Valve (DEVICE).
Who is sponsoring clinical trial NCT00630916?
This trial is sponsored by Sorin Group USA, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00630916 being conducted?
This trial has 20 study locations across Arizona, California, Indiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Valve Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00630916's enrollment target sits among peer trials
756 4th of 13 higher than 10 of 13 other Heart Valve Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Valve Diseases 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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