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German Registry for Transcatheter Tricuspid Valve Interventions

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ClinicalTrials.gov Identifier: NCT04653428
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
Heart and Diabetes Center North Rhine-Westphalia
Heart Center Leipzig - University Hospital
Mainz University
Universitätsklinikum Köln
University Hospital, Essen
Information provided by (Responsible Party):
Prof. Dr. med. Jörg Hausleiter, LMU Klinikum

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

Condition or disease Intervention/treatment
Tricuspid Regurgitation Tricuspid Valve Insufficiency Heart Valve Device: Interventional treatment of tricuspid regurgitation

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: German Registry for Transcatheter Tricuspid Valve Interventions
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2030

Intervention Details:
  • Device: Interventional treatment of tricuspid regurgitation
    Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair


Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
Blood sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe symptomatic tricuspid regurgitation, who are not eligible for cardiac surgery due to a high risk of mortality.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653428


Contacts
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Contact: Jörg Hausleiter, MD +49 89 4400 72361 joerg.hausleiter@med.uni-muenchen.de
Contact: Daniel Braun, MD +4915254848306 daniel.braun@med.uni-muenchen.de

Locations
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Germany
Klinikum der LMU Muenchen Recruiting
Munich, Germany
Contact: Jörg Hausleiter         
Sponsors and Collaborators
LMU Klinikum
Heart and Diabetes Center North Rhine-Westphalia
Heart Center Leipzig - University Hospital
Mainz University
Universitätsklinikum Köln
University Hospital, Essen
Investigators
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Principal Investigator: Jörg Hausleiter, MD Klinikum der LMU Muenchen
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Responsible Party: Prof. Dr. med. Jörg Hausleiter, Professor, LMU Klinikum
ClinicalTrials.gov Identifier: NCT04653428    
Other Study ID Numbers: D-TRIK
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Prof. Dr. med. Jörg Hausleiter, LMU Klinikum:
Tricuspid regurgiation
Tricuspid valve insufficiency
Interventional treatment
Heart valve diseases
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases