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NCT Number: NCT06400342

Randomized Evaluation for Failed TAVR

REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting

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Key information

Conditions

Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthetic Valve Malfunction

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV
  • Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II
  • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
  • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.

Exclusion criteria

  • Ongoing sepsis, including active endocarditis;
  • Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
  • Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
  • Pregnancy or intent to become pregnant for the next 12 months;

Coronary obstruction risk:

  • Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.

Treatment and study plan

TAVR-explant

Procedure

Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.

Redo-TAVR

Device

Repeat transcatheter aortic valve implantation within a failed THV.

Other names: Valve-in-Valve, TAV-in-TAV

Primary outcomes

  1. Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes

    Time frame: 30 days

    Time to first event of any components of the composite endpoint.

  2. Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes

    Time frame: 12 months

    Time to first event of any components of the composite endpoint.

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days

    Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality

  2. All-cause mortality

    Time frame: 12 months

    Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality

  3. Stroke

    Time frame: 30 days

  4. Stroke

    Time frame: 12 months

  5. Rehospitalization for cardiovascular causes

    Time frame: 30 days

  6. Rehospitalization for cardiovascular causes

    Time frame: 12 months

  7. Reintervention hospital length of stay (days)

    Time frame: 30 days

  8. Cardiovascular mortality

    Time frame: 30 days

    Death meeting one of the following criteria:

    • related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause
    • Intraprocedural death
    • Sudden death
    • Death of unknown cause

    Valve-related mortality

    • Death presumed to be related to bioprosthetic valve dysfunction

  9. Cardiovascular mortality

    Time frame: 12 months

    Death meeting one of the following criteria:

    • related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause
    • Intraprocedural death
    • Sudden death
    • Death of unknown cause

    Valve-related mortality

    • Death presumed to be related to bioprosthetic valve dysfunction

  10. VARC-3 bleeding

    Time frame: 30 days

  11. VARC-3 bleeding

    Time frame: 12 months

  12. Vascular and access-related complications

    Time frame: 30 days

  13. Vascular and access-related complications

    Time frame: 12 months

  14. Cardiac structural complications

    Time frame: 30 days

  15. Cardiac structural complications

    Time frame: 12 months

  16. Other acute procedural and technical valve-related complications

    Time frame: 30 days

  17. Other acute procedural and technical valve-related complications

    Time frame: 12 months

  18. Conduction disturbance requiring permanent pacemaker implantation

    Time frame: 30 days

  19. Conduction disturbance requiring permanent pacemaker implantation

    Time frame: 12 months

  20. Acute kidney injury

    Time frame: 30 days

  21. Acute kidney injury

    Time frame: 12 months

  22. Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)

    Time frame: 30 days

  23. Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)

    Time frame: 12 months

  24. Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.

    Time frame: 30 days

  25. Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.

    Time frame: 12 months

  26. Echocardiographic assessment of prosthetic valve performance

    Time frame: 30 days

  27. Echocardiographic assessment of prosthetic valve performance

    Time frame: 12 months

  28. Change in NYHA class from Baseline

    Time frame: 30 days

  29. Change in NYHA class from Baseline

    Time frame: 12 months

  30. Change in Quality of life (KCCQ) from Baseline

    Time frame: 30 days

    The KCCQ has a 0-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

  31. Change in Quality of life (KCCQ) from Baseline

    Time frame: 12 months

    The KCCQ has a 0-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

  32. Technical Success

    Time frame: 30 days

    • Freedom from mortality
    • Successful access, delivery of the device and retrieval of the delivery system
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location
    • Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

  33. Device Success (for Redo-TAVR)

    Time frame: 30 days

    • Technical success
    • Freedom from mortality
    • Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
    • Intended performance of the valve

  34. Safety Composite Endpoints

    Time frame: 30 days

    • Early safety, which includes freedom from all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities and surgery or intervention related to the device.
    • Clinical efficacy
    • Valve-related long-term clinical efficacy

  35. Technical Success

    Time frame: 12 months

    Same as above (Technical Success outcome 34)

  36. Device Success (for Redo-TAVR)

    Time frame: 12 months

    Same as above (Device Success (for Redo-TAVR) outcome 35)

  37. Safety Composite Endpoints

    Time frame: 12 months

    Same as above (Safety Composite Endpoints outcome 36)

Study contacts

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

Jake Sutton

CONTACT

[email protected]

202-877-6624

Kassandra Lopez

CONTACT

[email protected]

202-877-2452

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)

Acronym: REVIVE-TAVR

Important dates

Study start
2025
Primary completion
2034
Study completion
2036
First posted
May 6, 2024
Registry last updated
Jan 24, 2025

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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