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Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Intermediate Risk of Mortality (DEDICATE)

Primary Purpose

Aortic Valve Stenosis

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcatheter aortic valve implantation
Surgical aortic valve replacement
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Surgical aortic valve replacement, Low to intermediate operative risk

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Heart team consensus that TAVI and SAVR are both medically justified and advisable based on:

    1. Degenerative aortic valve stenosis with echocardiographically derived criteria:

      • Mean gradient >40 mmHg or
      • Jet velocity greater than 4.0 m/s or
      • Aortic valve area (AVA) of < 1.0 cm2 (indexed effective orifice area < 0.6cm2/m2).
    2. Patient is symptomatic from his/her aortic valve stenosis

      • New York Heart Association Functional Class ≥ II or
      • Angina pectoris or
      • Syncope.
    3. Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE).
    4. A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus.
  2. Patient has provided written informed consent to participate in the trial.
  3. Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures.
  4. The patient agrees to undergo SAVR, if randomized to control treatment.
  5. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
  6. Patients aged 65 to 85 years.
  7. Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause.

Exclusion Criteria:

  1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  2. Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus
  3. Previous cardiac surgery
  4. Any percutaneous coronary intervention performed within 1 month prior to the study procedure
  5. Untreated severe mitral or tricuspid regurgitation
  6. Untreated severe mitral stenosis
  7. Hemodynamic instability requiring inotropic support or mechanical circulatory support
  8. Ischemic stroke or intracranial bleeding within 1 month
  9. Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by resting echocardiogram
  10. Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient
  11. Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis
  12. Any other condition considered a contraindication for an isolated aortic valve procedure
  13. Symptomatic carotid or vertebral artery disease
  14. Expected life expectancy < 12 months due to associated non-cardiac comorbidities
  15. Currently participating in another investigational drug or device trial

Sites / Locations

  • Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen
  • Universitäts-Herzzentrum Freiburg-Bad Krozingen
  • Kerckhoff-Klinik Bad Nauheim
  • Herz- und Gefässklinik Bad Neustadt/Saale
  • Herz- und Diabeteszentrum NRW Bad Oeynhausen
  • Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)
  • Charité Universitätsmedizin Berlin (Campus Mitte)
  • Charité Universitätsmedizin Berlin (Campus Virchow)
  • Deutsches Herzzentrum Berlin
  • Vivantes Friedrichshain
  • Vivantes Humboldt Kliniken
  • Vivantes Klinikum am Urban
  • Vivantes Neukölln
  • Immanuel Klinikum Bernau
  • Kliniken der Ruhr-Universität Bochum
  • Medizinische Hochschule Brandenburg Theodor Fontane
  • Herzzentrum Dresden an der Technischen Universität Dresden
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen, Klinikum für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum
  • Universitätsklinikum Frankfurt
  • Universitäts-Herzzentrum Freiburg-Bad Krozingen
  • Universitätsklinikum Giessen und Marburg
  • Universitätsmedizin Greifswald / Klinikum Karlsburg
  • Universitätsklinikum Göttingen
  • Universitätsklinikum Halle (Saale)
  • Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Jena
  • Universitätsklinikum Schleswig-Holstein
  • Bundeswehrzentralkrankenhaus Koblenz
  • Herzzentrum der Uniklinik Köln
  • Deutsches Herzzentrum Leipzig
  • Universitäres Herzzentrum Lübeck
  • Otto-von Guericke-Universität Magdeburg
  • Universitätsmedizin Mainz
  • Deutsches Herzzentrum München
  • LMU Klinikum der Universität München
  • Universitätsklinikum Münster
  • Universitätsklinikum Regensburg
  • Robert Bosch Krankenhaus
  • Universitätsklinikum Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transcatheter aortic valve implantation

Surgical aortic valve replacement

Arm Description

Transcatheter aortic valve implantation (TAVI) using the most appropriate CE (Conformité Européene)-marked device available, with a minimum demand of experience of 30 implanted devices/type per center.

Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference.

Outcomes

Primary Outcome Measures

Freedom from stroke or death
(Efficacy endpoint)
Freedom from stroke or death
(Safety endpoint)

Secondary Outcome Measures

Freedom from stroke or death
will be assessed at every study visit and compared between TAVI and SAVR groups
Overall survival
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from cardiovascular mortality
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from the composite of all-cause mortality and stroke
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from myocardial infarction
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from stroke
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from major or life-threatening / disabling bleeding
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from acute kidney injury
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from vascular access site and access-related complications
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from conduction disturbances and arrhythmias, need for permanent pacemaker implantation
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from residual aortic regurgitation ≥ moderate
will be assessed at every study visit and compared between TAVI and SAVR groups
Composite device success
Number of participants with freedom from procedural mortality and correct positioning of a single transcatheter heart valve (THV) in the proper position with intended performance (no prosthesis- patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Composite early safety
Number of participants dying and/or number of participants with stroke (disabling and non-disabling), and/or life-threatening bleeding and/or acute kidney injury stages 2/3 and/or coronary artery obstruction requiring Intervention and/or major vascular complication and/or valve-related dysfunction requiring repeat procedure.
Composite clinical efficacy
Number or participants dying and/or number of participants with stroke (disabling and non-disabling) and/or rehospitalisation for worsening heart failure or valve-related symptoms and/or New York Heart Association functional class (NYHA) III or IV and/or valve-related dysfunction (mean aortic valve gradient >20 mmHg, effective orifice area (EOA) <0.9-1.1 cm2 and/or Doppler Velocity Index (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Freedom from prosthetic valve dysfunction
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from prosthetic aortic valve endocarditis
will be assessed at every study visit and compared between TAVI and SAVR groups
Freedom from the composite time-related valve safety
Number of participants with structural valve deterioration (including repeat procedures, prosthetic valve endocarditis and/or thrombosis) and/or number of participants with thromboembolic events (stroke) and/or Valve Academic Research Consortium (VARC-2) bleeding (unless clearly unrelated to valve therapy).
Quality of life measures
Number of participants with reduced quality of life measures after valve replacement as compared to baseline levels prior to valve-replacement, assessed using EuroQol five dimensions (EQ-5D) questionnaire and/or Barthel Index and/or center for epidemiologic studies depression (CES-D) Scale.
Health economic analysis
Incremental cost-effectiveness of TAVI compared to surgical valve replacement, by using quality adjusted life years (QALYs).
Number of (re) hospitalisations
Number rehospitalisations of all participants. Length of stay in hospital

Full Information

First Posted
March 21, 2017
Last Updated
October 10, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Deutsche Herzstiftung e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT03112980
Brief Title
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Intermediate Risk of Mortality
Acronym
DEDICATE
Official Title
Randomized, Multi-Center, Event-Driven Trial of TAVI Versus SAVR in Patients With Symptomatic Severe Aortic Valve Stenosis and Intermediate Risk of Mortality, as Assessed by STS-Score - DEDICATE
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Deutsche Herzstiftung e.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR, as measured by all-cause mortality or stroke after 1 and 5 years.
Detailed Description
A paradigm-shift towards performing TAVI in intermediate- and low-risk patients has already begun, as procedural results of TAVI have improved significantly within the past years. Nevertheless, a prospective and independent comparison of surgical (SAVR) and interventional (TAVI) valve therapy in patients considered at low to intermediate risk that covers an "all-comers" patient population and multiple devices has not yet been performed. The DEDICATE-trial is designed as a prospectively randomized (1:1), multi-center, comparator-controlled interventional trial to investigate whether transcatheter aortic valve implantation (TAVI) is non-inferior - as measured by all-cause mortality or stroke after 1 and 5 years - compared to surgical aortic valve replacement (SAVR) in the treatment of patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality, as assessed by the local Heart Team.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Surgical aortic valve replacement, Low to intermediate operative risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter aortic valve implantation
Arm Type
Experimental
Arm Description
Transcatheter aortic valve implantation (TAVI) using the most appropriate CE (Conformité Européene)-marked device available, with a minimum demand of experience of 30 implanted devices/type per center.
Arm Title
Surgical aortic valve replacement
Arm Type
Active Comparator
Arm Description
Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference.
Intervention Type
Device
Intervention Name(s)
Transcatheter aortic valve implantation
Intervention Description
(TAVI)
Intervention Type
Procedure
Intervention Name(s)
Surgical aortic valve replacement
Intervention Description
(SAVR)
Primary Outcome Measure Information:
Title
Freedom from stroke or death
Description
(Efficacy endpoint)
Time Frame
within 5 years after randomization
Title
Freedom from stroke or death
Description
(Safety endpoint)
Time Frame
within 1 year after randomization
Secondary Outcome Measure Information:
Title
Freedom from stroke or death
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Overall survival
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from cardiovascular mortality
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from the composite of all-cause mortality and stroke
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from myocardial infarction
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from stroke
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from major or life-threatening / disabling bleeding
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from acute kidney injury
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from vascular access site and access-related complications
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from conduction disturbances and arrhythmias, need for permanent pacemaker implantation
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from residual aortic regurgitation ≥ moderate
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Composite device success
Description
Number of participants with freedom from procedural mortality and correct positioning of a single transcatheter heart valve (THV) in the proper position with intended performance (no prosthesis- patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Time Frame
Five years after last patient in
Title
Composite early safety
Description
Number of participants dying and/or number of participants with stroke (disabling and non-disabling), and/or life-threatening bleeding and/or acute kidney injury stages 2/3 and/or coronary artery obstruction requiring Intervention and/or major vascular complication and/or valve-related dysfunction requiring repeat procedure.
Time Frame
within first 30 days after procedure
Title
Composite clinical efficacy
Description
Number or participants dying and/or number of participants with stroke (disabling and non-disabling) and/or rehospitalisation for worsening heart failure or valve-related symptoms and/or New York Heart Association functional class (NYHA) III or IV and/or valve-related dysfunction (mean aortic valve gradient >20 mmHg, effective orifice area (EOA) <0.9-1.1 cm2 and/or Doppler Velocity Index (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Time Frame
within first 30 days after procedure
Title
Freedom from prosthetic valve dysfunction
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from prosthetic aortic valve endocarditis
Description
will be assessed at every study visit and compared between TAVI and SAVR groups
Time Frame
Five years after last patient in
Title
Freedom from the composite time-related valve safety
Description
Number of participants with structural valve deterioration (including repeat procedures, prosthetic valve endocarditis and/or thrombosis) and/or number of participants with thromboembolic events (stroke) and/or Valve Academic Research Consortium (VARC-2) bleeding (unless clearly unrelated to valve therapy).
Time Frame
Five years after last patient in
Title
Quality of life measures
Description
Number of participants with reduced quality of life measures after valve replacement as compared to baseline levels prior to valve-replacement, assessed using EuroQol five dimensions (EQ-5D) questionnaire and/or Barthel Index and/or center for epidemiologic studies depression (CES-D) Scale.
Time Frame
Five years after last patient in
Title
Health economic analysis
Description
Incremental cost-effectiveness of TAVI compared to surgical valve replacement, by using quality adjusted life years (QALYs).
Time Frame
Five years after last patient in
Title
Number of (re) hospitalisations
Description
Number rehospitalisations of all participants. Length of stay in hospital
Time Frame
Five years after last patient in

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart team consensus that TAVI and SAVR are both medically justified and advisable based on: Degenerative aortic valve stenosis with echocardiographically derived criteria: Mean gradient >40 mmHg or Jet velocity greater than 4.0 m/s or Aortic valve area (AVA) of < 1.0 cm2 (indexed effective orifice area < 0.6cm2/m2). Patient is symptomatic from his/her aortic valve stenosis New York Heart Association Functional Class ≥ II or Angina pectoris or Syncope. Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE). A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus. Patient has provided written informed consent to participate in the trial. Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures. The patient agrees to undergo SAVR, if randomized to control treatment. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits. Patients aged 65 to 85 years. Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause. Exclusion Criteria: Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus Previous cardiac surgery Any percutaneous coronary intervention performed within 1 month prior to the study procedure Untreated severe mitral or tricuspid regurgitation Untreated severe mitral stenosis Hemodynamic instability requiring inotropic support or mechanical circulatory support Ischemic stroke or intracranial bleeding within 1 month Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by resting echocardiogram Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis Any other condition considered a contraindication for an isolated aortic valve procedure Symptomatic carotid or vertebral artery disease Expected life expectancy < 12 months due to associated non-cardiac comorbidities Currently participating in another investigational drug or device trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Blankenberg, MD
Organizational Affiliation
Universitäres Herz- und Gefäßzentrum Hamburg (UHZ), Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jochen Cremer, MD
Organizational Affiliation
Universitätsklinikum Schleswig-Holstein, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen
City
Aachen
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg-Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Kerckhoff-Klinik Bad Nauheim
City
Bad Nauheim
Country
Germany
Facility Name
Herz- und Gefässklinik Bad Neustadt/Saale
City
Bad Neustadt an der Saale
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW Bad Oeynhausen
City
Bad Oeynhausen
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)
City
Berlin
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin (Campus Mitte)
City
Berlin
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin (Campus Virchow)
City
Berlin
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
Country
Germany
Facility Name
Vivantes Friedrichshain
City
Berlin
Country
Germany
Facility Name
Vivantes Humboldt Kliniken
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum am Urban
City
Berlin
Country
Germany
Facility Name
Vivantes Neukölln
City
Berlin
Country
Germany
Facility Name
Immanuel Klinikum Bernau
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Kliniken der Ruhr-Universität Bochum
City
Bochum
Country
Germany
Facility Name
Medizinische Hochschule Brandenburg Theodor Fontane
City
Brandenburg an der Havel
Country
Germany
Facility Name
Herzzentrum Dresden an der Technischen Universität Dresden
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum Essen, Klinikum für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg-Bad Krozingen
City
Freiburg
Country
Germany
Facility Name
Universitätsklinikum Giessen und Marburg
City
Giessen
Country
Germany
Facility Name
Universitätsmedizin Greifswald / Klinikum Karlsburg
City
Greifswald / Karlsburg
Country
Germany
Facility Name
Universitätsklinikum Göttingen
City
Göttingen
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle (Saale)
Country
Germany
Facility Name
Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Bundeswehrzentralkrankenhaus Koblenz
City
Koblenz
ZIP/Postal Code
56076
Country
Germany
Facility Name
Herzzentrum der Uniklinik Köln
City
Köln
Country
Germany
Facility Name
Deutsches Herzzentrum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitäres Herzzentrum Lübeck
City
Lübeck
Country
Germany
Facility Name
Otto-von Guericke-Universität Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Universitätsmedizin Mainz
City
Mainz
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
München
Country
Germany
Facility Name
LMU Klinikum der Universität München
City
München
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
Country
Germany
Facility Name
Robert Bosch Krankenhaus
City
Stuttgart
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Intermediate Risk of Mortality

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