Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study (REVASC-TAVI)
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|ClinicalTrials.gov Identifier: NCT02797158|
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Severe and Symptomatic Aortic Stenosis Stable Coronary Disease||Procedure: TAVI procedure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||June 23, 2016|
|Actual Primary Completion Date :||July 15, 2019|
|Actual Study Completion Date :||July 15, 2019|
|Experimental: Interventional Arm||
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 [ Time Frame: 6 months ]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.
- The primary endpoint is a composite of stroke [ Time Frame: 6 months ]
- The primary endpoint is a composite of major bleeding [ Time Frame: 6 months ]Major bleedings are defined by ≥2 BARC classification.
- The primary endpoint is a composite of major vascular complication [ Time Frame: 6 months ]Access site complications is defined in accordance with the Valve Academic Research Consortium (VARC) guidelines.
- The primary endpoint is a composite of periprocedural myocardial infarction [ Time Frame: 6 months ]Perprocedural myocardial infarction is defined by 5-fold increased of basal troponin level associated to angina or ECG changes
- 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 [ Time Frame: 1 and 6 months ]ventricular fibrillation (VF), ventricular tachycardia (VT) requiring cardioversion, cardiopulmonary arrest requiring cardiopulmonary resuscitation (CPR) and/or assisted mechanical respiratory support
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797158
|Montpellier University Hospital|
|Montpellier, France, 34295|
|Principal Investigator:||Florence LECLERCQ, PU PH||Montpellier University Hospital|