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New treatment option for Mitral Regurgitation
Official title STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
ClinicalTrials.gov ID: NCT06901466
What this study is testing
What is Experimental: Rivaroxaban monotherapy?
Experimental: Rivaroxaban monotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mitral regurgitation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR.
- Phase 4: studies an already-approved treatment
- 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
Adults
You may be able to join if
- Successful TEER procedure, defined as technical success per MVARC criteria.
- Indication for long-term OAC.
- Ability and willingness to comply with the trial protocol.
- Provision of written informed consent.
- Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy.
You likely can't join if
- Severe renal impairment (creatinine clearance \< 15 mL/min or requiring dialysis).
- Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or...
- Platelet count \< 50 × 10\^9 /L.
- Need for reoperation due to complications of the index TEER procedure.
- Recent ( \< 12 month) intracranial or intracerebral hemorrhage.
- Recent ( \< 12 month) gastrointestinal ulcers or hemorrhage.
See the full eligibility criteria
- Successful TEER procedure, defined as technical success per MVARC criteria.
- Indication for long-term OAC.
- Ability and willingness to comply with the trial protocol.
- Provision of written informed consent.
- Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy.
- Antithrombotic strategy approved by the investigator.
- Severe renal impairment (creatinine clearance \< 15 mL/min or requiring dialysis).
- Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure.
- Platelet count \< 50 × 10\^9 /L.
- Need for reoperation due to complications of the index TEER procedure.
- Recent ( \< 12 month) intracranial or intracerebral hemorrhage.
- Recent ( \< 12 month) gastrointestinal ulcers or hemorrhage.
- Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis).
- Allergy, intolerance, or contraindication to research drugs.
- Participation in another investigational drug or device study within 30 days.
- History of stroke or TIA within the past 6 weeks.
- Absolute indication for anticoagulation in combination with antiplatelet therapy (eg, recent PCI).
- Life expectancy \< 12 months.
- Pregnancy or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.