225 Participants Needed

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

(RESTORE Trial)

Recruiting at 46 trial locations
RS
Overseen ByRESTORE Study Clinical Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Cardiovascular
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Who Is on the Research Team?

GA

Guilherme Attizzani, MD

Principal Investigator

UH, Cleveland Medical Center

BR

Basel Ramlawi

Principal Investigator

Lankenau Heart Institute

GF

Gregory Fontana, MD

Principal Investigator

Los Robles Regional Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I need a second TAVR due to valve failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo redo Transcatheter Aortic Valve Replacement (TAVR) procedure

Up to 7 days
In-hospital stay until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Visits at 30 days, 1 year, and annually thereafter

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials
78
Recruited
37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

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