Hamburg AoRtic Valve cOhoRt
HARbOR
Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt
1 other identifier
observational
15,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2039
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2049
January 13, 2020
January 1, 2020
20 years
January 9, 2020
January 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Myocardial Infarction
30 days after index procedure
Stroke
30 days after procedure
Vascular complications and bleeding
30 days after procedure
Durability of the implanted aortic valve prosthesis
10 years
Eligibility Criteria
The medical condition being studied is aortic valve disease
You may qualify if:
- Patients with clinically relevant aortic valve disease (aortic valve stenosis, aortic regurgitation, degenerated aortic valve prosthesis)
- Written informed consent
You may not qualify if:
- Insufficient knowledge of the German language (able to understand and write the German language)
- Physical or psychological incapability to take part in the investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitäres Herz- und Gefäßzentrum
Hamburg, 20246, Germany
Related Publications (1)
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.
PMID: 34156524DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moritz Seiffert, MD
University Heart Center Hamburg
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 13, 2020
Study Start
September 1, 2019
Primary Completion (Estimated)
September 1, 2039
Study Completion (Estimated)
September 1, 2049
Last Updated
January 13, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share