Randomized Evaluation for Failed TAVR (REVIVE-TAVR)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prosthesis Failure; Prosthetic Valve Malfunction; Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
• Intervention / Treatment: Procedure: TAVR-explant; Device: Redo-TAVR

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jake Sutton; Phone Number: 202-877-6624; Email: joseph.a.sutton@medstar.net
• Study Contact Backup: Name: Kassandra Lopez; Phone Number: 202-877-2452; Email: kassandra.lopez@medstar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAVR-explant; TAVR surgical explantation	Procedure: TAVR-explant; Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.
Active Comparator: Redo-TAVR; TAV-in-TAV	Device: Redo-TAVR; Repeat transcatheter aortic valve implantation within a failed THV.; Other Names: Valve-in-Valve, TAV-in-TAV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke		12 months
Stroke		30 days
Acute kidney injury		30 days
All-cause mortality	Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality	30 days
All-cause mortality	Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality	12 months
Rehospitalization for cardiovascular causes		30 days
Rehospitalization for cardiovascular causes		12 months
Reintervention hospital length of stay (days)		30 days
Cardiovascular mortality	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	30 days
Cardiovascular mortality	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	12 months
VARC-3 bleeding		30 days
VARC-3 bleeding		12 months
Vascular and access-related complications		30 days
Vascular and access-related complications		12 months
Cardiac structural complications		30 days
Cardiac structural complications		12 months
Other acute procedural and technical valve-related complications		30 days
Other acute procedural and technical valve-related complications		12 months
Conduction disturbance requiring permanent pacemaker implantation		30 days
Conduction disturbance requiring permanent pacemaker implantation		12 months
Acute kidney injury		12 months
Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)		30 days
Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)		12 months
Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.		30 days
Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.		12 months
Echocardiographic assessment of prosthetic valve performance		30 days
Echocardiographic assessment of prosthetic valve performance		12 months
Change in NYHA class from Baseline		30 days
Change in NYHA class from Baseline		12 months
Change in Quality of life (KCCQ) from Baseline	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.	30 days
Change in Quality of life (KCCQ) from Baseline	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.	12 months
Technical Success	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	30 days
Device Success (for Redo-TAVR)	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	30 days
Safety Composite Endpoints	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	30 days
Technical Success	Same as above (Technical Success outcome 34)	12 months
Device Success (for Redo-TAVR)	Same as above (Device Success (for Redo-TAVR) outcome 35)	12 months
Safety Composite Endpoints	Same as above (Safety Composite Endpoints outcome 36)	12 months

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Ron Waksman, MD, MedStar Health Research Organization; Study Chair: 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 record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): May 1, 2036

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Prosthesis Failure
• Other Study ID Numbers: REVIVE-TAVR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes