RECRUITINGN/A

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

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).

Sponsor

Medtronic Cardiovascular

Enrollment

225 participants

Sites

70 locations

Start Date

February 2025

Completion

March 2029

Aortic StenosisMedtronic TAVEdwards TAV

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

225

participants

Sites

locations

Duration

8.4 years

total trial span

Rate

pts/month needed

Feb 2025Month 14 of 101Mar 2029

14% of trial timeline elapsed87 months to primary endpoint

At 70 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

Primary Outcome Measure

Early (30-days)

30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGN/A

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

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).

Sponsor

Medtronic Cardiovascular

Enrollment

225 participants

Sites

70 locations

Start Date

February 2025

Completion

March 2029

Aortic StenosisMedtronic TAVEdwards TAV

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

225

participants

Sites

locations

Duration

8.4 years

total trial span

Rate

pts/month needed

Feb 2025Month 14 of 101Mar 2029

14% of trial timeline elapsed87 months to primary endpoint

At 70 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Primary Outcome Measure

Early (30-days)

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

105 Years

Sex

all

Healthy Volunteers

View full criteria

Inclusion Criteria:

* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Exclusion Criteria:

* BVF due solely to paravalvular regurgitation
* Active endocarditis
* Untreated acute valve thrombosis
* Life-expectancy less than 1-year
* Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
* Participating in another study that may influence the outcome of this study

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Sutter Heatlh

Sacramento, California, United States

Kaiser Permanente Northern California

Sacramento, California, United States

Stanford Hospital & Clinics

Stanford, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

+60 more sites

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (70)