Randomized Evaluation for Failed TAVR

Prosthesis Failure Clinical Trial

— REVIVE-TAVR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400342
• Other study ID #: REVIVE-TAVR
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2036

Study information

• Verified date: May 2024
• Source: Medstar Health Research Institute
• Contact: Kassandra Lopez
• Phone: 202-877-2452
• Email: kassandra.lopez[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: May 1, 2036
• Est. primary completion date: May 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthetic Valve Malfunction

Intervention

Procedure:
• TAVR-explant
Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.

Device:
• Redo-TAVR
Repeat transcatheter aortic valve implantation within a failed THV.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Outcome

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