NCT02797158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

June 23, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

September 30, 2025

Status Verified

May 1, 2019

Enrollment Period

3.1 years

First QC Date

May 30, 2016

Last Update Submit

September 24, 2025

Conditions

Severe and Symptomatic Aortic StenosisStable Coronary Disease

Keywords

TAVIAortic stenosisCoronary artery diseaseCoronary angiographyPercutaneous Coronary InterventionMyocardial ischemiaSPECTCoronary revascularization

Outcome Measures

Primary Outcomes (6)

  • 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.

    6 months

  • The primary endpoint is a composite of stroke

    6 months

  • The primary endpoint is a composite of major bleeding

    Major bleedings are defined by ≥2 BARC classification.

    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.

    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

    6 months

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

    6 months

Secondary Outcomes (13)

  • Post-TAVI mortality

    1 and 6 months

  • Major adverse cardiovascular or cerebrovascular event (MACCE)

    1 and 6 months

  • Acute coronary syndrome (ACS)

    1 and 6 months

  • Acute myocardial infarction (MI)

    1 and 6 months

  • Rate of stroke

    1 and 6 months

  • +8 more secondary outcomes

Study Arms (1)

Interventional Arm

EXPERIMENTAL
Procedure: TAVI procedure

Interventions

TAVI procedurePROCEDURE

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

Interventional Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aortic Valve StenosisCoronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Florence LECLERCQ, PU PH

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 13, 2016

Study Start

June 23, 2016

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

September 30, 2025

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)