Randomized Evaluation for Failed TAVR

NCT06400342 | Not Yet Recruiting FDA Device

• 1 other identifier: REVIVE-TAVR
• Study Type: interventional
• Target: 264
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure; Prosthetic Valve Malfunction; Prosthesis Failure

Outcome Measures

Primary Outcomes (2)

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

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

  30 days

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

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

  12 months

Secondary Outcomes (37)

• All-cause mortality

  30 days

• All-cause mortality

  12 months

• Stroke

  30 days

• Stroke

  12 months

• Rehospitalization for cardiovascular causes

  30 days

Study Arms (2)

TAVR-explant

ACTIVE COMPARATOR

TAVR surgical explantation

Procedure: TAVR-explant

Redo-TAVR

ACTIVE COMPARATOR

TAV-in-TAV

Device: Redo-TAVR

Interventions

TAVR-explant PROCEDURE

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

TAVR-explant

Redo-TAVR DEVICE

Repeat transcatheter aortic valve implantation within a failed THV.

Also known as: Valve-in-Valve, TAV-in-TAV

Redo-TAVR

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ron Waksman, MD

  MedStar Health Research Organization

  PRINCIPAL INVESTIGATOR

• Toby Rogers, MD

  MedStar Health Research Organization

  STUDY CHAIR

• Thomas MacGillivray, MD

  MedStar Health Research Organization

  STUDY CHAIR

• Michael Reardon, MD

  MedStar Health Research Organization

  STUDY CHAIR

• Kalyan Chitturi, DO

  MedStar Health Research Organization

  STUDY CHAIR

Central Study Contacts

Kassandra Lopez

CONTACT

202-877-2452; kassandra.lopez@medstar.net

Jake Sutton

CONTACT

202-877-6624; Joseph.A.Sutton@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects deemed eligible for both redo-TAVR and TAVR-explant by the Heart Team for the treatment of failed THV will be randomized on a 1:1 basis to either redo-TAVR or TAVR-explant.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: May 6, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): May 1, 2036
• Last Updated: January 24, 2025

Record last verified: 2025-01