Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt
Hamburg AoRtic Valve cOhoRt
Sponsors
Source
Universitätsklinikum Hamburg-Eppendorf
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Is Us Export
Yes
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.
Overall Status
Recruiting
Start Date
2019-09-01
Completion Date
2049-09-01
Primary Completion Date
2039-09-01
Study Type
Observational [Patient Registry]
Primary Outcome
Measure |
Time Frame |
|
All cause mortality |
one year |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Enrollment
15000
Condition
Eligibility
Study Pop
The medical condition being studied is aortic valve disease
Sampling Method
Non-Probability Sample
Criteria
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Moritz Seiffert, MD |
Principal Investigator |
University Heart Center Hamburg |
Overall Contact
Last Name
Moriz Seiffert, MD
Phone
+49407410
Phone Ext
58206
m.seiffert@uke.de
Location
Facility |
Status |
Contact |
Investigator |
|
Universitäres Herz- und Gefäßzentrum Hamburg 20246 Germany |
Recruiting |
Last Name: Moritz Seiffert, MD Phone: +49407410 Phone Ext: 58206 Email: m.seiffert@uke.de |
Last Name: Moritz Seiffert, MD Role: Principal Investigator |
Location Countries
Country
Germany
Verification Date
2020-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Niklas Schofer, MD
Phone
+49407410
Phone Ext
58206
n.schofer@uke.de
Acronym
HARbOR
Target Duration
10 Years
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
January 9, 2020
Study First Submitted Qc
January 9, 2020
Study First Posted
January 13, 2020
Last Update Submitted
January 9, 2020
Last Update Submitted Qc
January 9, 2020
Last Update Posted
January 13, 2020
ClinicalTrials.gov processed this data on May 08, 2026
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.