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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 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.

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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.

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

FieldValue
Enrollment Target 756 participants
Start Date 2003-11
Est. Completion 2007-12
Phase NA

Sponsor

Sorin Group USA

6 total trials

What the Registry Record Tells You About NCT00630916

The ClinicalTrials.gov registry entry for NCT00630916 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 756 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,027-participant average among 13 other Heart Valve Diseases trials with a reported enrollment target (26% lower). The listed sponsor is Sorin Group USA, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.