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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment Phase
Severe and Symptomatic Aortic Stenosis Stable Coronary Disease Procedure: TAVI procedure Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : June 23, 2016
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. The primary endpoint is a composite of stroke [ Time Frame: 6 months ]
  3. The primary endpoint is a composite of major bleeding [ Time Frame: 6 months ]
    Major bleedings are defined by ≥2 BARC classification.

  4. 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.

  5. 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

  6. The primary endpoint is a composite of hospitalization for cardiac cause. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Post-TAVI mortality [ Time Frame: 1 and 6 months ]
  2. Major adverse cardiovascular or cerebrovascular event (MACCE) [ Time Frame: 1 and 6 months ]
  3. Acute coronary syndrome (ACS) [ Time Frame: 1 and 6 months ]
  4. Acute myocardial infarction (MI) [ Time Frame: 1 and 6 months ]
  5. Rate of stroke [ Time Frame: 1 and 6 months ]
  6. Repeat revascularization by either PCI or CABG [ Time Frame: 1 and 6 months ]
  7. Hospitalization for heart failure or for non cardiovascular causes [ Time Frame: 1 and 6 months ]
  8. Duration of hospital stay [ Time Frame: 1 and 6 months ]
  9. Quality of life by Kansas city cardiomyopathy questionnaire [ Time Frame: 1 and 6 months ]
  10. 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

  11. percentage of pacemaker after implantation of the valve [ Time Frame: 1 and 6 months ]
  12. Bleeding complications according to the BARC classification [ Time Frame: 1 and 6 months ]
  13. Severe VARC Access Site Complications (Safety Issue at 1 and 6 months) [ Time Frame: 1 and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Montpellier University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Florence LECLERCQ, PU PH Montpellier University Hospital

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02797158     History of Changes
Other Study ID Numbers: 9674
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: May 2019

Keywords provided by University Hospital, Montpellier:
TAVI
Aortic stenosis
Coronary artery disease
Coronary angiography
Percutaneous Coronary Intervention
Myocardial ischemia
SPECT
Coronary revascularization

Additional relevant MeSH terms:
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Coronary Disease
Coronary Artery Disease
Aortic Valve Stenosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction