Hamburg AoRtic Valve cOhoRt (HARbOR)

Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis

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 Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Moriz Seiffert, MD; Phone Number: 58206 +49407410; Email: m.seiffert@uke.de
• Study Contact Backup: Name: Niklas Schofer, MD; Phone Number: 58206 +49407410; Email: n.schofer@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitäres Herz- und Gefäßzentrum
    • Principal Investigator: Moritz Seiffert, MD
    • Contact: Moritz Seiffert, MD; Phone Number: 58206 +49407410; Email: m.seiffert@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The medical condition being studied is aortic valve disease

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Stroke	Assessment of clinical disability using a modified Rankin Scale (mRS) within the first 30 days after index procedure	30 days after procedure
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
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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Moritz Seiffert, MD, University Heart Center Hamburg

Publications and helpful links

General Publications

• Westermann D, Ludwig S, Kalbacher D, Spink C, Linder M, Bhadra OD, Nikorowitsch J, Waldschmidt L, Demal T, Voigtlander L, Schaefer A, Seiffert M, Pecha S, Schofer N, Greenbaum AB, Reichenspurner H, Blankenberg S, Conradi L, Schirmer J. Prevention of coronary obstruction in patients at risk undergoing transcatheter aortic valve implantation: the Hamburg BASILICA experience. Clin Res Cardiol. 2021 Dec;110(12):1900-1911. doi: 10.1007/s00392-021-01881-4. Epub 2021 Jun 22. Erratum In: Clin Res Cardiol. 2021 Oct;110(10):1693.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2039
• Study Completion (ANTICIPATED): September 1, 2049

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: HARBOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes