Outcome, Recuperation and Hemodynamics in Aortic Stenosis (PROCARE-AS)

Jessa Hospital

Status: Unknown

Conditions: Aortic Valve Stenosis

Treatments: Diagnostic Test: CPET, 6MWT, QOL assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05272020

f/2020/173

Details and patient eligibility

About

Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Every patient above 18 years of age with an echocardiographic established moderate to severe AS
• A guideline indication for aortic valve replacement therapy

Exclusion criteria

• Unable to perform exercise testing
• Previous aortic valve intervention
• More than moderate other valvular disease
• Patients refusing participation or unwilling to sign the informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

TAVI

Other group

Description:

Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment

Treatment:

Diagnostic Test: CPET, 6MWT, QOL assessment

AVR

Other group

Description:

Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy

Treatment:

Diagnostic Test: CPET, 6MWT, QOL assessment