Trials Sponsors Conditions Drugs Pricing

Conditions

Severe and Symptomatic Aortic Stenosis Stable 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

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

University Hospital, Montpellier
Otherlead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

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
University Hospital, Montpellier
PRINCIPAL INVESTIGATOR

Enrollment

71 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (1)

Interventional Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (13)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (1)

Interventional Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (13)

You may not qualify if:

Data Sharing

Source record

Locations