Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED NA

Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

NCT00630916 · View on ClinicalTrials.gov ↗

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

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00630916

The ClinicalTrials.gov registry entry for NCT00630916 describes a study currently listed as completed. It is categorized as NA, 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 756 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sorin Group USA, which has 1 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 Heart Valve Diseases appearing as the primary indexed condition, and to 1 intervention — of which Mitroflow Aortic Heart Valve 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: NCT00630916 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Pennsylvania, Texas, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00630916?

The interventions under investigation include: Mitroflow Aortic Heart Valve (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00630916?

This trial is sponsored by Sorin Group USA, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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