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Trial record 2 of 606 for:    "Aortic valve stenosis"

Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry (FinnValve)

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ClinicalTrials.gov Identifier: NCT03385915
Recruitment Status : Enrolling by invitation
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Collaborators:
Helsinki University Central Hospital
Oulu University Hospital
Tampere University Hospital
Kuopio University Hospital
Information provided by (Responsible Party):
Fausto Biancari, Turku University Hospital

Brief Summary:
The FinnValve investigators planned a nationwide registry to investigate the early and late outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic valve stenosis performed from 2008 to 2017 at five Finnish University Hospitals. Data will be collected in a dedicated electronic case report form.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: Aortic valve replacement

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TAVI cohort
Patients who underwent transcatheter aortic valve implantation for aortic valve stenosis
Procedure: Aortic valve replacement
Transcatheter or surgical aortic valve replacement for severe aortic valve stenosis

SAVR cohort
Patients who underwentsurgical aortic valve replacement for aortic valve stenosis
Procedure: Aortic valve replacement
Transcatheter or surgical aortic valve replacement for severe aortic valve stenosis




Primary Outcome Measures :
  1. Death [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    All-cause death


Secondary Outcome Measures :
  1. Atrial fibrillation [ Time Frame: During the index hospital stay, an average of 7 days ]
    Any episode of atrial fibrillation

  2. Permanent pace-maker implantation [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    Permanent pace-maker implantation

  3. Stroke [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    Stroke

  4. Infection [ Time Frame: During the index hospital stay, an average of 7 days ]
    Deep sternal wound infection/mediastinitis, vascular access site infection, pneumonia, sepsis

  5. Acute kidney injury [ Time Frame: During the index hospital stay, an average of 7 days ]
    Postoperative acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

  6. Bleeding [ Time Frame: During the index hospital stay, an average of 7 days ]
    Minor, major, life-threatening or disabling bleeding according to the VARC 2 definition criteria

  7. Reoperation for bleeding [ Time Frame: During the index hospital stay, an average of 7 days ]
    Reoperation for bleeding

  8. Postoperative intra-aortic balloon pump [ Time Frame: During the index hospital stay, an average of 7 days ]
    Postoperative use of intra-aortic balloon pump

  9. Venoarterial extracorporeal oxygenation [ Time Frame: During the index hospital stay, an average of 7 days ]
    Postoperative use of venoarterial extracorporeal oxygenation

  10. Intensive care unit stay [ Time Frame: During the index hospital stay, an average of 7 days ]
    Length of stay in the intensive care unit

  11. Structural valve deterioration [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    • Mean transprosthetic gradient ≥40 mmHg
    • Mean transprosthetic gradient ≥20 mmHg change from baseline
    • Severe intraprosthetic regurgitation, new or worsening (>2+/4+) from baseline

  12. Prosthesis thrombosis [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment

  13. Prosthesis endocarditis [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    Prosthesis endocarditis requiring medical or surgical treatment

  14. Repeat procedure [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    Repeat procedure on the aortic valve

  15. Myocardial infarction [ Time Frame: From discharge after the index procedure till the end of the follow-up period (December 2017) ]
    Myocardial infarction occurring after discharge after the index procedure

  16. Coronary revascularization [ Time Frame: From the index procedure till the end of the follow-up period (December 2017) ]
    Coronary revascularization after discharge after the index procedure

  17. Paravalvular regurgitation [ Time Frame: During the index hospital stay, an average of 7 days ]
    Paravalvular regurgitation immediately after the index procedure

  18. TAVI/SAVR prosthesis migration [ Time Frame: During the index hospital stay, an average of 7 days ]
    TAVI/SAVR prosthesis migration

  19. Annulus rupture [ Time Frame: During the index hospital stay, an average of 7 days ]
    Rupture of the aortic annulus

  20. Coronary artery ostium occlusion [ Time Frame: During the index hospital stay, an average of 7 days ]
    Coronary artery ostium occlusion during the index procedure

  21. Ventricular septal perforation [ Time Frame: During the index hospital stay, an average of 7 days ]
    Ventricular septal perforation during the index procedure

  22. Mitral valve apparatus damage or dysfunction [ Time Frame: During the index hospital stay, an average of 7 days ]
    Mitral valve apparatus damage or dysfunction during the index procedure

  23. Tamponade [ Time Frame: During the index hospital stay, an average of 7 days ]
    Pericardial tamponade during or immediately after the index procedure

  24. Vascular injury [ Time Frame: During the index hospital stay, an average of 7 days ]
    Vascular injury during the index procedure

  25. Injury of the left ventricle wall [ Time Frame: During the index hospital stay, an average of 7 days ]
    Injury of the left ventricle wall during the index procedure

  26. Need of emergency cardiac surgery [ Time Frame: During the index hospital stay, an average of 7 days ]
    Need of emergency cardiac surgery



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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 who underwent transcatheter (TAVI) or surgical aortic valve replacement (SAVR) for severe aortic valve stenosis at five Finnish University Hospitals from January 2008 to September 2017
Criteria

Inclusion Criteria:

  • Patients who underwent transcatheter (TAVI) or surgical aortic valve replacement (SAVR) for severe aortic valve stenosis
  • Patients aged >18 years
  • Primary aortic valve procedure with a bioprosthesis for AS with or without associated regurgitation.
  • TAVI and SAVR with or without associated coronary revascularization
  • TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze procedure and/or closure of the left atrial appendage.

Exclusion Criteria:

  • Patients who underwent any prior SAVR or TAVI
  • Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the ascending aorta.
  • Patients operated on for aortic valve endocarditis
  • Patients operated for isolated aortic valve regurgitation.

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): NCT03385915


Locations
Finland
Heart Center, Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Tampere University Hospital
Kuopio University Hospital

Responsible Party: Fausto Biancari, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03385915     History of Changes
Other Study ID Numbers: T309/2017
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fausto Biancari, Turku University Hospital:
Transcatheter aortic valve replacement
Transcatheter aortic valve implantation
TAVI
TAVR
Aortic valve replacement
Surgical aortic valve replacement
Sutureless

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction