CompletedNot Applicable

Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study

France71 participantsStarted 2016-06-23

Plain-language summary

Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients older than 18 years * Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main * Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision. Exclusion Criteria: * Recent acute coronary syndrome (within 30 days before randomization), * Unprotected left main disease * Critical stenosis (\>90%) of Left Anterior Descending artery (LAD), * Significant angina (CCS class more than 2) * Active bleeding, * Contraindication for tomographic technetium-99 assessment or dipyridamole injection * Previous enrollment in a other study * Impossibly to obtain consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary endpoint is a composite of all cause of death

Timeframe: 6 months

The primary endpoint is a composite of stroke

Timeframe: 6 months

The primary endpoint is a composite of major bleeding

Timeframe: 6 months

The primary endpoint is a composite of major vascular complication

Timeframe: 6 months

The primary endpoint is a composite of periprocedural myocardial infarction

Timeframe: 6 months

The primary endpoint is a composite of hospitalization for cardiac cause.

Timeframe: 6 months

Trial details

NCT IDNCT02797158

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-15

View on ClinicalTrials.gov More Severe and Symptomatic Aortic Stenosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The primary endpoint is a composite of all cause of death

Timeframe: 6 months

The primary endpoint is a composite of stroke

Timeframe: 6 months

The primary endpoint is a composite of major bleeding

Timeframe: 6 months

The primary endpoint is a composite of major vascular complication

Timeframe: 6 months

The primary endpoint is a composite of periprocedural myocardial infarction

Timeframe: 6 months

The primary endpoint is a composite of hospitalization for cardiac cause.

Timeframe: 6 months