Hamburg AoRtic Valve cOhoRt

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT04227002
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The primary aim of the study is to identify the optimal treatment modality for patients with aortic valve disease, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.

Detailed Description

Patients with severe aortic valve disease have a poor prognosis under medical therapy, making replacement of the failing valve the preferred option. In addition to surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI) has evolved as an alternative treatment option for patients at intermediate and high operative risk. Before expansion of TAVI to low-risk and younger patients can be recommended, several questions remain to be investigated, e.g. optimal patient selection, periprocedural complications and long-term durability. Therefore every patient with a relevant aortic valve disease (aortic stenosis, aortic regurgitation or degenerative aortic valve prosthesis) who meets the inclusion/exclusion criterias is planned to be involved in the study.

Predictors of outcome are yet to be defined in patients with aortic valve disease in order to improve risk prediction for the different treatment modalities (medical, SAVR, TAVI).

The primary aim of the study is to identify the optimal treatment modality for the individual patient, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Last Update Submitted: 2020-01-09
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2039-09-01
• Study Completion: 2049-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• Patients with clinically relevant aortic valve disease (aortic valve stenosis, aortic regurgitation, degenerated aortic valve prosthesis)
• Written informed consent

Exclusion Criteria

• Insufficient knowledge of the German language (able to understand and write the German language)
• Physical or psychological incapability to take part in the investigation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	one year	The primary aim of the study is to investigate all cause mortality after surgical aortic valve replacement or transcatheter aortic valve replacement. Events of death will be registered either from in-house information or telephone follow-up of the patient or the referring physician as part of clinical routine.

Secondary Outcome Measures

Name	Time	Method
Durability of the implanted aortic valve prosthesis	10 years	Evaluation of long time durability of the implanted aortic valve prosthesis by echocardiography in the yearly follow up.
Myocardial Infarction	30 days after index procedure	Myocardial infarction based on a combination of clinical criteria, ecg changes indicative of new ischemia and a significant rise in cardiac biomarkers (peak value exceeding 15 x as the upper reference limit for troponin or 5 x for CK-MB) within the first 72 hours (periprocedural myocardial infarction) or 30 days (spontaneous myocardial infarction) after index procedure
Stroke	30 days after procedure	Assessment of clinical disability using a modified Rankin Scale (mRS) within the first 30 days after index procedure
Vascular complications and bleeding	30 days after procedure	Evaluation of overt bleeding or vascular complications after index procedure by drop in haemoglobin and transfusion of packed red blood cells

Trial Locations

Locations (1)

Universitäres Herz- und Gefäßzentrum; 🇩🇪 Hamburg, Germany