Outcome, Recuperation and Hemodynamics in Aortic Stenosis

N/AUnknownNCT05272020

Jessa Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Aortic Valve Stenosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Outcome defined by the occurrence of a major cardiac event

either 1. Death of cardiovascular origin, or 2. Hospitalization for heart failure, or 3. Deterioration of hemodynamic function during an 18 month follow-up period after AVR.

Time frame: 18 months