Randomized Evaluation for Failed TAVR

N/ANot Yet RecruitingNCT06400342

Medstar Health Research Institute264 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

264

Conditions

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

Interventions

TAVR-explantPROCEDURE

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

Redo-TAVRDEVICE

Repeat transcatheter aortic valve implantation within a failed THV.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

Time frame: 30 days

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

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

Time frame: 12 months

Secondary Outcomes

All-cause mortality

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

Time frame: 30 days

All-cause mortality

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

Time frame: 12 months

Stroke

Time frame: 30 days

Stroke

Time frame: 12 months

Rehospitalization for cardiovascular causes

Time frame: 30 days

Rehospitalization for cardiovascular causes

Time frame: 12 months

Reintervention hospital length of stay (days)

Time frame: 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

Central Contacts

Kassandra Lopez

CONTACT

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

Jake Sutton

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Cardiovascular mortality

Time frame: 12 months

VARC-3 bleeding

Time frame: 30 days

VARC-3 bleeding

Time frame: 12 months

Vascular and access-related complications

Time frame: 30 days

Vascular and access-related complications

Time frame: 12 months

Cardiac structural complications

Time frame: 30 days

Cardiac structural complications

Time frame: 12 months

Other acute procedural and technical valve-related complications

Time frame: 30 days

Other acute procedural and technical valve-related complications

Time frame: 12 months

Conduction disturbance requiring permanent pacemaker implantation

Time frame: 30 days

Conduction disturbance requiring permanent pacemaker implantation

Time frame: 12 months

Acute kidney injury

Time frame: 30 days

Acute kidney injury

Time frame: 12 months

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

Time frame: 30 days

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

Time frame: 12 months

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

Time frame: 30 days

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

Time frame: 12 months

Echocardiographic assessment of prosthetic valve performance

Time frame: 30 days

Echocardiographic assessment of prosthetic valve performance

Time frame: 12 months

Change in NYHA class from Baseline

Time frame: 30 days

Change in NYHA class from Baseline

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 30 days

Technical Success

Same as above (Technical Success outcome 34)

Time frame: 12 months

Device Success (for Redo-TAVR)

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

Time frame: 12 months

Safety Composite Endpoints

Same as above (Safety Composite Endpoints outcome 36)

Time frame: 12 months