Status:
UNKNOWN
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
Lead Sponsor:
Erasmus Medical Center
Conditions:
Aortic Valve Stenosis
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
Detailed Description
The POTUS study is a prospective, investigator-initiated, single-arm observational study with invasive measurements that will consist of two cohorts. The first cohort consists of 120 patients with int...
Eligibility Criteria
Inclusion
- Age ≥ 18.
- a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team.
- b) TMVr cohort: severe functional/degenerative mitral regurgitation for which TMVr is scheduled after discussion in the Heart Team.
- At least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel ≥ 2.5 mm
- Elective procedure
- Written informed consent
Exclusion
- TAVI cohort: height coronary ostia \< 10 mm
- Severe chronic kidney disease, defined as estimated glomerular filtration rate \< 30 ml/min.
- Contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine.
- Degenerated surgical or transcatheter aortic valve bioprosthesis.
- 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05374733
Start Date
March 22 2021
End Date
March 1 2023
Last Update
May 16 2022
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands, 3015GD