Randomized Evaluation for Failed TAVR

NCT ID: NCT06400342

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2036-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVR-explant

TAVR surgical explantation

Group Type: ACTIVE_COMPARATOR

TAVR-explant

Intervention Type: PROCEDURE

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

Redo-TAVR

TAV-in-TAV

Group Type: ACTIVE_COMPARATOR

Redo-TAVR

Intervention Type: DEVICE

Repeat transcatheter aortic valve implantation within a failed THV.

Interventions

TAVR-explant

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

Intervention Type: PROCEDURE

Redo-TAVR

Repeat transcatheter aortic valve implantation within a failed THV.

Intervention Type: DEVICE

Other Intervention Names

Valve-in-Valve, TAV-in-TAV

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Health Research Organization

Toby Rogers, MD

Role: STUDY_CHAIR

MedStar Health Research Organization

Thomas MacGillivray, MD

Role: STUDY_CHAIR

MedStar Health Research Organization

Michael Reardon, MD

Role: STUDY_CHAIR

MedStar Health Research Organization

Kalyan Chitturi, DO

Role: STUDY_CHAIR

MedStar Health Research Organization

Central Contacts

Kassandra Lopez

Role: CONTACT

kassandra.lopez@medstar.net

202-877-2452

Jake Sutton

Role: CONTACT

Joseph.A.Sutton@medstar.net

202-877-6624

Other Identifiers

REVIVE-TAVR

Identifier Type: -

Identifier Source: org_study_id