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NCT Number: NCT04227002

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitäres Herz- und Gefäßzentrum

Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Moritz Seiffert, MD

CONTACT

[email protected]

+49407410 ext. 58206

Moritz Seiffert, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: 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 outcomes

  1. Myocardial Infarction

    Time frame: 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

  2. Stroke

    Time frame: 30 days after procedure

    Assessment of clinical disability using a modified Rankin Scale (mRS) within the first 30 days after index procedure

  3. Vascular complications and bleeding

    Time frame: 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

  4. Durability of the implanted aortic valve prosthesis

    Time frame: 10 years

    Evaluation of long time durability of the implanted aortic valve prosthesis by echocardiography in the yearly follow up.

Study contacts

Contact information is provided by the study sponsor or research team.

Moriz Seiffert, MD

CONTACT

[email protected]

+49407410 ext. 58206

Niklas Schofer, MD

CONTACT

[email protected]

+49407410 ext. 58206

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt

Acronym: HARbOR

Important dates

Study start
2019
Primary completion
2039
Study completion
2049
First posted
Jan 13, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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