BridgeMD
New treatment option for Mitral Valve Prolapse
Official title PRIMARY Ancillary Substudy
ClinicalTrials.gov ID: NCT07103733
What this study is testing
- What it's testing
- The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.
- 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 60 and older
You may be able to join if
- Patients who meet all eligibility criteria and are assigned by chance in the parent PRIMARY trial.
- For the ancillary biospecimen study, patients who are assigned by chance to MVr in the parent trial.
You likely can't join if
- Severe claustrophobia not controlled with sedation.
- Prior adverse reaction to gadolinium administration.
- Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be...
- Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Atlanta, Georgia, United States
- Portland, Maine, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Charlottesville, Virginia, United States
- Morgantown, West Virginia, United States
- Berlin, Germany
- Leipzig, Germany
- Trumpington, Cambridge, United Kingdom
- Leeds, England, United Kingdom
- Whitechapel, London, United Kingdom
- Oxford, Manchester, United Kingdom
+ 3 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, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Atlanta, Georgia, United States; Portland, Maine, United States; Baltimore, Maryland, United States and 17 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.