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NCT02803957 · ClinicalTrials.gov registry record · NA
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
A NA study of Mitral Valve Insufficiency, sponsored by NeoChord.
- Recruiting
- Registry status
- NA
- Development phase
- 585
- Enrollment target
- 18
- Study locations
NCT02803957 is a NA study of Mitral Valve Insufficiency that is actively recruiting participants, run by NeoChord. The registered enrollment target is 585 participants, above the 333-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (76% higher). The trial reports 18 study locations across 13 states.
The verdict
NCT02803957, a NA study of Mitral Valve Insufficiency, is actively recruiting participants, sponsored by NeoChord.
- RECRUITING
- Registry status
- NA
- Development phase
- 585 participants
- Enrollment target
- 18
- Study locations
Study Summary
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
Conditions Studied
Interventions
- DEVICE NeoChord DS1000
- DEVICE Surgical Mitral Valve Repair
Study Locations (18)
California
- Sutter Health/Alta Bates Summitt Medical Center - Oakland
- Mercy General Hospital - Sacramento
- Stanford University - Stanford
Pennsylvania
- Pinnacle Health - Harrisburg
- Penn State Milton S. Hershey Medical Center - Hershey
- University of Pittsburgh Medical Center - Pittsburgh
New York
- Mount Sinai, Icahn School of Medicine - New York
- Columbia University Medical Center - New York
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- Florida Hospital - Orlando
Georgia
- Piedmont Heart Institute - Atlanta
Indiana
- Franciscan Health - Indianapolis
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 585 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2027-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02803957
The ClinicalTrials.gov registry entry for NCT02803957 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 585 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 333-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (76% higher). The listed sponsor is NeoChord, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Mitral Valve Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which NeoChord DS1000 is the first listed.
NCT02803957 reports 18 study locations spanning 13 distinct geographic areas - top geographies include California, Pennsylvania, New York.
Frequently Asked Questions
What is clinical trial NCT02803957 about?
NCT02803957 is a clinical study titled "Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair". The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgica...
What is the current status of trial NCT02803957?
This trial is currently recruiting. It is a NA study. The enrollment target is 585 participants. The study started on 2016-11-03. Estimated completion is 2027-07.
What conditions does trial NCT02803957 study?
This clinical trial studies the following conditions: Mitral Valve Insufficiency.
What interventions are being tested in trial NCT02803957?
The interventions under investigation include: NeoChord DS1000 (DEVICE), Surgical Mitral Valve Repair (DEVICE).
Who is sponsoring clinical trial NCT02803957?
This trial is sponsored by NeoChord, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02803957 being conducted?
This trial has 18 study locations across California, District of Columbia, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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