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New treatment option for Mitral Valve Regurgitation
Official title Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
ClinicalTrials.gov ID: NCT03242642
What this study is testing
- What it's testing
- Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Moderate to severe or severe symptomatic mitral regurgitation
- Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved...
You likely can't join if
- prior transcatheter mitral valve procedure with device currently implanted
- anatomic contraindications
- prohibitive mitral annular calcification
- left ventricular ejection fraction \<25%
- need for emergent or urgent surgery
- hemodynamic instability
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Mountain View, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Thousand Oaks, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Atlantis, Florida, United States
- Clearwater, Florida, United States
- Fort Myers, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Des Moines, Iowa, United States
+ 45 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Mountain View, California, United States; San Francisco, California, United States and 59 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.