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NCT Number: NCT04653428

German Registry for Transcatheter Tricuspid Valve Interventions

Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum der LMU Muenchen

Munich, Germany

Location status: Recruiting

Location contact

Jörg Hausleiter

CONTACT

About this study

Severe tricuspid regurgitation occurs in around 1.5 % of men and 5.6 % of women and it is associated with significant morbidity and mortality. Current guidelines recommend cardiac surgery, especially in those patients who are undergoing left side valve surgery. Nevertheless many patients are not eligible for surgical tricuspid valve repair due to an high risk of mortality. Therefore interventional devices for treatment of tricuspid regurgitation have been established to offer these patients an alternative treatment option. The aim of this study is to analyse the success and saftey aspects of different interventional repair techniques for severe tricuspid regurgitation. Therefore in this prospectively designed observational study clinical, echocardiographic and laboratory parameters will be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
  • Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.

Exclusion criteria

  • No agreement to participation
  • Age < 18 years

Treatment and study plan

Interventional treatment of tricuspid regurgitation

Device

Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair

Primary outcomes

  1. All-cause death and heart failure hospitalisation

    Time frame: 1 year

    All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)

Secondary outcomes

  1. All-cause death and heart failure hospitalisation (long-term)

    Time frame: up to 5 years

    Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)

  2. All-cause death and heart failure hospitalisation (short-term)

    Time frame: 30-90 days

    Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)

  3. Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)

    Time frame: up to 5 years

    Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale.

  4. Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)

    Time frame: up to 5 years

    Assessment for cardiopulmonal symptoms include edema scaling

  5. Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)

    Time frame: up to 5 years

    NYHA classification I, II, III or IV

  6. Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)

    Time frame: up to 5 years

    Assessed by standardized protocol testing 6-minute walking distance

  7. Change of quality of life after transcatheter tricuspid valve treatment (TTVT)

    Time frame: up to 5 years

    Quality of life is assessed by standardized questionnaires including the Minnesota Living with Heart Failure Questionnaire

  8. Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)

    Time frame: up to 5 years

    N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in pg/ml

  9. Procedural success after transcatheter tricuspid valve treatment (TTVT)

    Time frame: At the day of discharge after transcatheter tricuspid valve treatment (TTVT)

    Procedural success is defined as a reduction of the tricuspid regurgitation to at least grade 2+ achieved by interventional treatment

Other outcomes

  1. Safety outcome after transcatheter tricuspid valve treatment (TTVT)

    Time frame: At the day of discharge after transcatheter tricuspid valve treatment (TTVT)

    The saftety outcome contains all complications which occur between the interventional treatment of the tricuspid regurgitation and discharge from the hospital. Data collection includes: mortality with differentiation of cardiac death and non-cardiac death, unplanned cardiac surgery, re-intervention of tricuspid valve, pericardial tamponade, intervention of coronary arteries. Moreover major adverse events as defined by MVARC2 criteria are recorded at discharge from hospital: death with differentiation of cardiac death and non-cardiac death, peri-procedural or spontaneous myocardial infarction, stroke, transient ischemic attack, life-threatening, major or minor bleeding, acute kidney failure, complications of the vascular access.

Study contacts

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

Daniel Braun, MD

CONTACT

[email protected]

+4915254848306

Jörg Hausleiter, MD

CONTACT

[email protected]

+49 89 4400 72361

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Collaborators

  • Heart Center Leipzig - University Hospital
  • Heart and Diabetes Center North Rhine-Westphalia
  • Mainz University
  • University Hospital, Essen
  • Universitätsklinikum Köln

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2030
First posted
Dec 4, 2020
Registry last updated
Dec 4, 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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