A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial

NCT01645202 | Completed DMC

• 1 other identifier: SK 107 -- 012/12 (II)
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis.

Conditions

Aortic Stenosis

Keywords

Aortic stenosis; TAVI; Device success; Aortic regurgitation

Outcome Measures

Primary Outcomes (1)

• 'Device success' as recently defined by the Valve Academic Research Consortium

  Device success is a 'technical' composite endpoint including successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, correct position of the device in the proper anatomical location, intended performance of the prosthetic heart valve (aortic valve area \> 1.2 cm2 and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, without moderate or severe prosthetic valve AR) and only one valve implanted in the proper anatomical location.

  Immediately after the procedure

Secondary Outcomes (2)

• VARC-defined combined safety endpoint

  30 days

• VARC-defined combined efficacy endpoint

  1 year

Study Arms (2)

TAVI with Edwards Sapien XT valve

ACTIVE COMPARATOR

Procedure: Transcatheter Aortic Valve Implantation (TAVI)

TAVI with Medtronic CoreValve

ACTIVE COMPARATOR

Procedure: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) PROCEDURE

Comparison of different types of valves

Also known as: Transcatheter Aortic Valve Replacement (TAVR)

TAVI with Edwards Sapien XT valve; TAVI with Medtronic CoreValve

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
• Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class ≥ 2
• Age \> 75 years and/or Logistic EuroSCORE ≥ 20% and/or STS risk score ≥ 10% and/or contraindication to conventional surgical aortic valve replacement (porcelain aorta, previous chest radiation, chest deformation)
• Native aortic valve annulus measuring 20-25 mm
• Patients must be suitable for a transfemoral vascular access
• The patient signing a written informed consent prior to intervention

You may not qualify if:

• Life expectancy \< 12 months due to co-morbid conditions
• Native aortic valve annulus \< 20 mm and \> 25 mm (this could be amended if further valve sizes for the transfemoral approach become available for both prostheses during the study period)
• Pre-existing aortic bioprosthesis
• Cardiogenic shock or hemodynamic instability
• History of, or active endocarditis
• Contraindications for a transfemoral access
• Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
• Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
• Active infection requiring antibiotic treatment
• An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 3 months post-enrolment
• Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period

Sponsors & Collaborators

• Segeberger Kliniken GmbH: lead

Study Sites (1)

Segeberger Kliniken GmbH / Herzzentrum

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

Related Publications (8)

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 BACKGROUND

• Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol. 2007 Jul 3;50(1):69-76. doi: 10.1016/j.jacc.2007.04.047. Epub 2007 Jun 6.

  PMID: 17601548 BACKGROUND

• Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8. doi: 10.1016/j.jacc.2011.08.050. Epub 2011 Oct 20.

  PMID: 22019110 BACKGROUND

• Abdel-Wahab M, Zahn R, Horack M, Gerckens U, Schuler G, Sievert H, Eggebrecht H, Senges J, Richardt G; German transcatheter aortic valve interventions registry investigators. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart. 2011 Jun;97(11):899-906. doi: 10.1136/hrt.2010.217158. Epub 2011 Mar 12.

  PMID: 21398694 BACKGROUND

• Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.

  PMID: 21050971 BACKGROUND

• Abdel-Wahab M, Landt M, Neumann FJ, Massberg S, Frerker C, Kurz T, Kaur J, Toelg R, Sachse S, Jochheim D, Schafer U, El-Mawardy M, Robinson DR, Richardt G; CHOICE Investigators. 5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 May 11;13(9):1071-1082. doi: 10.1016/j.jcin.2019.12.026. Epub 2020 Apr 15.

  PMID: 32305398 DERIVED

• Abdel-Wahab M, Neumann FJ, Mehilli J, Frerker C, Richardt D, Landt M, Jose J, Toelg R, Kuck KH, Massberg S, Robinson DR, El-Mawardy M, Richardt G; CHOICE Investigators. 1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):791-800. doi: 10.1016/j.jacc.2015.06.026.

  PMID: 26271061 DERIVED

• Abdel-Wahab M, Mehilli J, Frerker C, Neumann FJ, Kurz T, Tolg R, Zachow D, Guerra E, Massberg S, Schafer U, El-Mawardy M, Richardt G; CHOICE investigators. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA. 2014 Apr 16;311(15):1503-14. doi: 10.1001/jama.2014.3316.

  PMID: 24682026 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Mohamed Abdel-Wahab, MD

  Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany

  PRINCIPAL INVESTIGATOR

• Gert Richardt, MD

  Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: July 20, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2018
• Last Updated: July 26, 2019

Record last verified: 2019-02

Locations

DE (1)