Outcome, Recuperation and Hemodynamics in Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TAVI

Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment

Group Type OTHER

CPET, 6MWT, QOL assessment

Intervention Type DIAGNOSTIC_TEST

Preoperative and postoperative (6 months + 18 months) assessment

AVR

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

Group Type OTHER

CPET, 6MWT, QOL assessment

Intervention Type DIAGNOSTIC_TEST

Preoperative and postoperative (6 months + 18 months) assessment

Interventions

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CPET, 6MWT, QOL assessment

Preoperative and postoperative (6 months + 18 months) assessment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No