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NCT Number: NCT07623083

Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation

Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.

Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.

In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.

This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.

The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.

The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.

The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years.
  • Patients with severe AS undergoing transarterial TAVI.
  • Concomitant significant MR and/or TR (≥3+).

Exclusion criteria

  • Life expectancy <1 year due to noncardiac conditions.
  • Any prior mitral or tricuspid valve surgery.
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
  • Active endocarditis.
  • Subjects in whom transesophageal echocardiography is contraindicated or high risk.

Treatment and study plan

Primary outcomes

  1. All-cause mortality or re-hospitalization for worsening heart failure

    Time frame: Minimum of 1 year

    Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure

Secondary outcomes

  1. All-cause mortality or re-hospitalization for worsening heart failure

    Time frame: 1 Year

    Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.

  2. All-cause mortality or re-hospitalization for worsening heart failure

    Time frame: 2 year

    Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up

  3. All-cause mortality or re-hospitalization for worsening heart failure

    Time frame: 3 year

    Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.

  4. All-cause mortality or re-hospitalization for worsening heart failure

    Time frame: 4 year

    Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.

  5. All-cause mortality or re-hospitalization for worsening heart failure

    Time frame: 5 year

    Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.

  6. All-cause mortality

    Time frame: 1 year

    All-cause mortality at 1 year

  7. All-cause mortality

    Time frame: 2 year

    All-cause mortality at 2 year

  8. All-cause mortality

    Time frame: 3 year

    All-cause mortality at 3 year

  9. All-cause mortality

    Time frame: 4 year

    All-cause mortality at 4 year

  10. All-cause mortality

    Time frame: 5 year

    All-cause mortality at 5 year

  11. Heart failure re-hospitalization

    Time frame: 1 year

    Heart failure re-hospitalization at 1 year

  12. Heart failure re-hospitalization

    Time frame: 2 year

    Heart failure re-hospitalization at 2 year

  13. Heart failure re-hospitalization

    Time frame: 3 year

    Heart failure re-hospitalization at 3 year

  14. Heart failure re-hospitalization

    Time frame: 4 year

    Heart failure re-hospitalization at 4 year

  15. Heart failure re-hospitalization

    Time frame: 5 year

    Heart failure re-hospitalization at 5 year

  16. Cardiovascular mortality

    Time frame: 1 year

    Cardiovascular mortality at 1 year

  17. Cardiovascular mortality

    Time frame: 2 year

    Cardiovascular mortality at 2 year

  18. Cardiovascular mortality

    Time frame: 3 year

    Cardiovascular mortality at 3 year

  19. Cardiovascular mortality

    Time frame: 4 year

    Cardiovascular mortality at 4 year

  20. Cardiovascular mortality

    Time frame: 5 year

    Cardiovascular mortality at 5 year

  21. All-cause mortality or heart failure re-hospitalization

    Time frame: 1 year

    Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.

  22. MR severity

    Time frame: 1 year

    MR severity at 1 year

  23. MR severity

    Time frame: 2 year

    MR severity at 2 year

  24. MR severity

    Time frame: 3 year

    MR severity at 3 year

  25. MR severity

    Time frame: 4 year

    MR severity at 4 year

  26. MR severity

    Time frame: 5 year

    MR severity at 5 year

  27. TR severity

    Time frame: 1 year

    TR severity at 1 year

  28. TR severity

    Time frame: 2 year

    TR severity at 2 year

  29. TR severity

    Time frame: 3 year

    TR severity at 3 year

  30. TR severity

    Time frame: 4 year

    TR severity at 4 year

  31. TR severity

    Time frame: 5 year

    TR severity at 5 year

  32. LVEF

    Time frame: 1 year

    LVEF at 1 year

  33. LVEF

    Time frame: 2 year

    LVEF at 2 year

  34. LVEF

    Time frame: 3 year

    LVEF at 3 year

  35. LVEF

    Time frame: 4 year

    LVEF at 4 year

  36. LVEF

    Time frame: 5 year

    LVEF at 5 year

Study contacts

Contact information is provided by the study sponsor or research team.

Josep Rodes Cabau, MD PhD

CONTACT

[email protected]

14186568711 ext. 5593

Melanie Côté, MSc

CONTACT

[email protected]

4186568711 ext. 2646

Sponsors and collaborators

Lead sponsor

Josep Rodes-Cabau

Other

Registry information

Official study title

Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation

Acronym: MASTER-TAVI II

Important dates

Study start
2026
Primary completion
2029
Study completion
2034
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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