BridgeMD
New treatment option for Mitral Regurgitation
Official title AltaValve Pivotal Trial
ClinicalTrials.gov ID: NCT06465745
What this study is testing
- What it's testing
- This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
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
- Age ≥ 18 years.
- Symptomatic New York Heart Association (NYHA) class II-IV.
- Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
- Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
You likely can't join if
- (Abbreviated List):
- Inability to understand the trial or a history of non-compliance with medical advice.
- Inability to provide signed Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with participation in the trial.
- Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might...
- Female people who are pregnant or planning to become pregnant within the trial period.
See the full eligibility criteria
- Age ≥ 18 years.
- Symptomatic New York Heart Association (NYHA) class II-IV.
- Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
- Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
- (Abbreviated List):
- Inability to understand the trial or a history of non-compliance with medical advice.
- Inability to provide signed Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with participation in the trial.
- Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of...
- Female people who are pregnant or planning to become pregnant within the trial period.
- Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
- Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
- Known hypersensitivity to contrast media that cannot be adequately medicated.
- Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
- Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- San Francisco, California, United States
- Thousand Oaks, California, United States
- Houma, Louisiana, United States
- Columbia, Maryland, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Bonn, Germany
+ 8 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 Phoenix, Arizona, United States; Tucson, Arizona, United States; San Francisco, California, United States; Thousand Oaks, California, United States; Houma, Louisiana, United States; Columbia, Maryland, United States and 22 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.