Health TrialsbyHealthPanel

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-105
SponsorMedtronic Cardiovascular

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

BVF due solely to paravalvular regurgitation

Active endocarditis

Untreated acute valve thrombosis

Life-expectancy less than 1-year

Trial population

The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Medtronic TAV

    Device

    Medtronic TAV where commercially available

  • Edwards TAV

    Device

    Edwards TAV where commercially available.

Treatment groups

225 Participants
are divided into 1 treatment group
Group A: Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)2 interventions

Trial outcomes

Primary outcomes

1

Primary Outcome Measure

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

Time frame
Early (30-days)
2

Primary Outcome Measure

a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes

Time frame
Late (1-year)

Secondary outcomes

1

Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)

(VARC) 3 technical success (at exit from procedure room)

Time frame
Time of procedure
2

VARC 3 30-day device success

30-day device success

Time frame
30-Day
3

VARC 3 30-day early safety

30-day early safety

Time frame
30-Day
4

Peak and mean invasive gradient post-procedure

Peak and mean invasive gradient will be measured in mmHg

Time frame
Time of procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Cardiovascular

Lead sponsor

Source ClinicalTrials.gov
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