Hamburg AoRtic Valve cOhoRt

Aortic Valve Stenosis Clinical Trial

— HARbOR  

Official title:

Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04227002
• Other study ID #: HARbOR
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: September 1, 2049

Study information

• Verified date: January 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Moriz Seiffert, MD
• Phone: +49407410
• Email: m.seiffert[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: September 1, 2049
• Est. primary completion date: September 1, 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Locations

Country	Name	City	State
Germany	Universitäres Herz- und Gefäßzentrum	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	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.	one year
Secondary	Myocardial Infarction	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	30 days after index procedure
Secondary	Stroke	Assessment of clinical disability using a modified Rankin Scale (mRS) within the first 30 days after index procedure	30 days after procedure
Secondary	Vascular complications and bleeding	Evaluation of overt bleeding or vascular complications after index procedure by drop in haemoglobin and transfusion of packed red blood cells	30 days after procedure
Secondary	Durability of the implanted aortic valve prosthesis	Evaluation of long time durability of the implanted aortic valve prosthesis by echocardiography in the yearly follow up.	10 years