Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

Not Applicable

• Conditions: Aortic Valve Stenosis; Mitral Regurgitation; Coronary Artery Disease; Fractional Flow Reserve
• Interventions: Diagnostic Test: Coronary Physiology assessment

• Registration Number: NCT05374733
• Lead Sponsor: Erasmus Medical Center

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 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 Timeline

• Study Start: 2021-03-22
• Study First Submitted: 2021-09-21
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-13
• Study First Posted: 2022-05-16
• Last Update Posted: 2022-05-16
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Coronary Physiology assessment	Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention.

Primary Outcome Measures

Name	Time	Method
The change in the FFR value before and after TAVI	Directly before and after the TAVI procedure (1 hour)	The impact of TAVI on FFR
The change in the FFR value before and after TMVr	Directly before and after the TMVr procedure (1 hour)	The impact of TMVr on FFR

Secondary Outcome Measures

Name	Time	Method
The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on Pd/Pa
The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on CFR
The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on dPR
The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on the transvalvular gradient
The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on hemodynamics
The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on RFR
The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on the LVEDP
The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on hemodynamics
The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)	Directly before and after the TAVI/TMVr procedure (1 hour)	The impact of TAVI/TMVr on IMR

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands