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

NCT ID: NCT03112980

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2028-01-31

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcatheter aortic valve implantation

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.

Group Type: EXPERIMENTAL

Transcatheter aortic valve implantation

Intervention Type: DEVICE

(TAVI)

Surgical aortic valve replacement

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

Group Type: ACTIVE_COMPARATOR

Surgical aortic valve replacement

Intervention Type: PROCEDURE

(SAVR)

Interventions

Transcatheter aortic valve implantation

(TAVI)

Intervention Type: DEVICE

Surgical aortic valve replacement

(SAVR)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

The German Heart Foundation

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Blankenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Universitäres Herz- und Gefäßzentrum Hamburg (UHZ), Germany

Jochen Cremer, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Schleswig-Holstein, Germany

Locations

Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen

Aachen, , Germany

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, , Germany

Kerckhoff-Klinik Bad Nauheim

Bad Nauheim, , Germany

Herz- und Gefässklinik Bad Neustadt/Saale

Bad Neustadt an der Saale, , Germany

Herz- und Diabeteszentrum NRW Bad Oeynhausen

Bad Oeynhausen, , Germany

Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)

Berlin, , Germany

Charité Universitätsmedizin Berlin (Campus Mitte)

Berlin, , Germany

Charité Universitätsmedizin Berlin (Campus Virchow)

Berlin, , Germany

Deutsches Herzzentrum Berlin

Berlin, , Germany

Vivantes Friedrichshain

Berlin, , Germany

Vivantes Humboldt Kliniken

Berlin, , Germany

Vivantes Klinikum am Urban

Berlin, , Germany

Vivantes Neukölln

Berlin, , Germany

Immanuel Klinikum Bernau

Bernau, , Germany

Kliniken der Ruhr-Universität Bochum

Bochum, , Germany

Medizinische Hochschule Brandenburg Theodor Fontane

Brandenburg, , Germany

Herzzentrum der Uniklinik Köln

Cologne, , Germany

Herzzentrum Dresden an der Technischen Universität Dresden

Dresden, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Universitätsklinikum Essen, Klinikum für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum

Essen, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Freiburg im Breisgau, , Germany

Universitätsklinikum Giessen und Marburg

Giessen, , Germany

Universitätsklinikum Göttingen

Göttingen, , Germany

Universitätsmedizin Greifswald / Klinikum Karlsburg

Greifswald / Karlsburg, , Germany

Universitätsklinikum Halle (Saale)

Halle, , Germany

Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Jena

Jena, , Germany

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Bundeswehrzentralkrankenhaus Koblenz

Koblenz, , Germany

Deutsches Herzzentrum Leipzig

Leipzig, , Germany

Universitäres Herzzentrum Lübeck

Lübeck, , Germany

Otto-von Guericke-Universität Magdeburg

Magdeburg, , Germany

Universitätsmedizin Mainz

Mainz, , Germany

Deutsches Herzzentrum München

München, , Germany

LMU Klinikum der Universität München

München, , Germany

Universitätsklinikum Münster

Münster, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Robert Bosch Krankenhaus

Stuttgart, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Countries

Germany

References

Seiffert M, Vonthein R, Baumgartner H, Borger MA, Choi YH, Falk V, Frey N, Hagendorff A, Hagl C, Hamm C, Konig IR, Landmesser U, Massberg S, Reichenspurner H, Thiele H, Twerenbold R, Vens M, Walther T, Ziegler A, Cremer J, Blankenberg S. Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low to intermediate surgical risk: rationale and design of the randomised DEDICATE Trial. EuroIntervention. 2023 Oct 23;19(8):652-658. doi: 10.4244/EIJ-D-23-00232.

Reference Type: BACKGROUND

PMID: 37655862 (View on PubMed)

Blankenberg S, Seiffert M, Vonthein R, Baumgartner H, Bleiziffer S, Borger MA, Choi YH, Clemmensen P, Cremer J, Czerny M, Diercks N, Eitel I, Ensminger S, Frank D, Frey N, Hagendorff A, Hagl C, Hamm C, Kappert U, Karck M, Kim WK, Konig IR, Krane M, Landmesser U, Linke A, Maier LS, Massberg S, Neumann FJ, Reichenspurner H, Rudolph TK, Schmid C, Thiele H, Twerenbold R, Walther T, Westermann D, Xhepa E, Ziegler A, Falk V; DEDICATE-DZHK6 Trial Investigators. Transcatheter or Surgical Treatment of Aortic-Valve Stenosis. N Engl J Med. 2024 May 2;390(17):1572-1583. doi: 10.1056/NEJMoa2400685. Epub 2024 Apr 8.

Reference Type: BACKGROUND

PMID: 38588025 (View on PubMed)

Other Identifiers

DEDICATE - DZHK 6

Identifier Type: OTHER

Identifier Source: secondary_id

DEDICATE

Identifier Type: -

Identifier Source: org_study_id