Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

Erasmus Medical Center150 enrolled

Overview

Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.

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 intermediate coronary artery disease who undergo a transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis ('TAVI cohort'). The second cohort consists of 30 patients with intermediate coronary artery disease who undergo transcatheter mitral valve repair (TMVr) for functional/degenerative mitral regurgitation ('TMVr cohort'). Both cohorts will undergo a battery of coronary physiological tests both before and after the valvular intervention. Additionally, in the case that the fractional flow reserve (FFR) over a coronary lesion is significant (i.e. FFR ≤ 0.80) during the post valvular intervention measurements, additional percutaneous coronary intervention (PCI) will take place during the same procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Aortic Valve Stenosis Mitral Regurgitation Coronary Artery Disease Fractional Flow Reserve

Interventions

Coronary Physiology assessmentDIAGNOSTIC_TEST

1. Pd/Pa, diastolic pressure ratio (dPR), resting full cycle ratio (RFR), FFR, coronary flow reserve (CFR), and index of microvascular resistance (IMR) measurements in the coronary of interest before the valvular intervention. 2. Pd/Pa, dPR, RFR, FFR, vFFR, CFR and IMR measurements in the coronary of interest after the valvular intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Outcomes

Primary Outcomes

The change in the FFR value before and after TAVI

The impact of TAVI on FFR

Time frame: Directly before and after the TAVI procedure (1 hour)

The change in the FFR value before and after TMVr

The impact of TMVr on FFR

Time frame: Directly before and after the TMVr procedure (1 hour)