Coronary Physiology Peri-Transcatheter Left-sided Valvular interventions in Patients with Severe Aortic Stenosis or Mitral Regurgitatio

Recruiting

• Conditions: coronary artery disease; valvular heart disease; 10011082

• Registration Number: NL-OMON53992
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Age >= 18.
2. a. TAVI Cohort: severe aortic valve stenosis for which TAVI is scheduled
after discussion in the Heart Team.
b. TVMR Cohort: severe functional mitral regurgitation for which TVMR
is scheduled after discussion in the Heart Team.
3. At least intermediate coronary artery disease, defined as 50 - 99% DS in a
vessel >=2.5 mm.
4. Elective procedure.
5. Written informed consent.

Exclusion Criteria

1. TAVI cohort: height coronary ostia < 10 mm.
2. Severe chronic kindey disease, defined as estimated glomerular filtration
rate < 30 ml/min.
3. Contra-indication for intravenous adenosine (severe asthma or chronic
obstructive pulmonary disease, known allergy to adenosine or precious reported
bronchospasm in response to adenosine).
4. Degenerated surgical or transcatheter aortic valve bioprosthesis.
5. Vessels that have collaterals to a chronic total occlusion or that are
supplied by an arterial or venous bypass graft will not be interrogated in this
study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in the FFR value before and after transcatheter left-sided valvular<br /><br>intervention (i.e. TAVI or TMVR).</p><br>