An interventional study of TAVI procedure in Severe and Symptomatic Aortic Stenosis and Stable Coronary Disease, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment
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.
Background: Percutaneous coronary intervention (PCI) is usually proposed to patients with aortic stenosis (AS) before TransAortic Valve Implantation (TAVI) when significant coronary stenosis is detected on preprocedural coronary angiography. However, the benefit of a systematic revascularisation is unknown and may have specific complications in elderly and frail patients.
Aims: The investigators proposed 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.
Methods: This prospective open label clinical trial will include 71 consecutive patients with significant coronary artery disease (CAD) defined by one or more significant coronary stenosis in patients admitted for TAVI. Myocardial SPECT imaging will be performed in all patients at 1-month follow-up after the TAVI procedure. Targeted PCI will be performed only in patients with significant related ischemia (> 10 % myocardial perfusion defect).
The primary outcome criterion is a composite criterion of feasibility and safety including all causes of death, stroke, major bleedings, major vascular complications, per procedural myocardial infarction, coronary revascularization or rehospitalisation for cardiac cause at 6 month follow-up.
Hypothesis: An alternative management of CAD guided by significant myocardial ischemia detection after TAVI could reduce the risk of unnecessary revascularization, the complications and the costs inherent to these procedures and a phase II trial is requiring to the evaluate this innovative and less invasive strategy.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 71 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: TAVI procedure
Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
The primary endpoint is a composite of all cause of death
Mortality is defined as death due to any cause, the exact nature and date of which will be recorded. All deaths will be considered cardiovascular-related unless there is documentation to the contrary.
Time frame: 6 months
The primary endpoint is a composite of stroke
Time frame: 6 months
The primary endpoint is a composite of major bleeding
Major bleedings are defined by ≥2 BARC classification.
Time frame: 6 months
The primary endpoint is a composite of major vascular complication
Access site complications is defined in accordance with the Valve Academic Research Consortium (VARC) guidelines.
Time frame: 6 months
The primary endpoint is a composite of periprocedural myocardial infarction
Perprocedural myocardial infarction is defined by 5-fold increased of basal troponin level associated to angina or ECG changes
Time frame: 6 months
The primary endpoint is a composite of hospitalization for cardiac cause.
Time frame: 6 months
Post-TAVI mortality
Time frame: 1 and 6 months
Major adverse cardiovascular or cerebrovascular event (MACCE)
Time frame: 1 and 6 months
Acute coronary syndrome (ACS)
Time frame: 1 and 6 months
Acute myocardial infarction (MI)
Time frame: 1 and 6 months
Rate of stroke
Time frame: 1 and 6 months
Repeat revascularization by either PCI or CABG
Time frame: 1 and 6 months
Hospitalization for heart failure or for non cardiovascular causes
Time frame: 1 and 6 months
Duration of hospital stay
Time frame: 1 and 6 months
Quality of life by Kansas city cardiomyopathy questionnaire
Time frame: 1 and 6 months
Per-procedural complications
ventricular fibrillation (VF), ventricular tachycardia (VT) requiring cardioversion, cardiopulmonary arrest requiring cardiopulmonary resuscitation (CPR) and/or assisted mechanical respiratory support
Time frame: 1 and 6 months
percentage of pacemaker after implantation of the valve
Time frame: 1 and 6 months
Bleeding complications according to the BARC classification
Time frame: 1 and 6 months
Severe VARC Access Site Complications (Safety Issue at 1 and 6 months)
Time frame: 1 and 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier