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

Aortic Stenosis Clinical Trial

— CHOICE  

Official title:

A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645202
• Other study ID #: SK 107 -- 012/12 (II)
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Segeberger Kliniken GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study design: randomized open-label multicenter

Primary endpoint:

'Device success' as recently defined by VARC which is a 'technical' composite endpoint including:

1. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system,

2. Correct position of the device in the proper anatomical location,

3. 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

4. Only one valve implanted in the proper anatomical location.

Secondary endpoints:

• 30-day-combined safety endpoint which is a combined endpoint defined by VARC as:

1. All cause mortality,

2. Major stroke,

3. Life threatening (or disabling) bleeding,

4. Acute kidney injury-Stage 3 (including renal replacement therapy),

5. Periprocedural myocardial infarction,

6. Major vascular complications and

7. Repeat procedure for valve-related dysfunction (surgical or interventional therapy). *

• Combined efficacy endpoint at 1 year which is a composite endpoint defined by VARC as:

1. All cause mortality between 30 days and one year,

2. Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiac decompensation and

3. Prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic valve gradient > 20 mmHg or peak velocity > 3 m/s or moderate or severe prosthetic valve AR). *

• Cardiovascular mortality as defined by VARC at 1 month, 6 and 12 months. *

• Major adverse cardiovascular and cerebrovascular events (MACCE): myocardial infarction, cardiac or vascular surgery and stroke at 30 days, 6 & 12 months.

• Rehospitalization for heart failure at 12 months

• Quality of life (assessed with the Euro5Qual-questionnaire) at 12 months

• NYHA-class improvement at 30 days, 6 and 12 months

• Vascular complication as defined by VARC at 30 days.

• Post-procedural pacemaker implantation at 1 month

• Major or minor Bleeding at 30 days as defined be VARC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 2018
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

1. Severe aortic valve stenosis defined as aortic valve area (AVA) = 1cm2 or 0.6 cm2/m2

2. Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class = 2

3. 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)

4. Native aortic valve annulus measuring 20-25 mm

5. Patients must be suitable for a transfemoral vascular access

6. The patient signing a written informed consent prior to intervention

Exclusion Criteria:

1. Life expectancy < 12 months due to co-morbid conditions

2. 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)

3. Pre-existing aortic bioprosthesis

4. Cardiogenic shock or hemodynamic instability

5. History of, or active endocarditis

6. Contraindications for a transfemoral access

7. Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.

8. Hypersensitivity or contraindication to aspirin, heparin or clopidogrel

9. Active infection requiring antibiotic treatment

10. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 3 months post-enrolment

11. Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Transcatheter Aortic Valve Implantation (TAVI)
Comparison of different types of valves

Locations

Country	Name	City	State
Germany	Segeberger Kliniken GmbH / Herzzentrum	Bad Segeberg	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Segeberger Kliniken GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

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. Epub 2007 Jun 6. — View Citation

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. — View Citation

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. — View Citation

Sherif MA, Abdel-Wahab M, Stöcker B, Geist V, Richardt D, Tölg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	'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	VARC-defined combined safety endpoint	Combined endpoint defined by VARC as: 1) All cause mortality, 2) Major stroke, 3) Life threatening (or disabling) bleeding, 4) Acute kidney injury-Stage 3 (including renal replacement therapy), 5) Periprocedural myocardial infarction, 6) Major vascular complications and 7) Repeat procedure for valve-related dysfunction (surgical or interventional therapy).	30 days
Secondary	VARC-defined combined efficacy endpoint	A composite endpoint defined by VARC as: 1) All cause mortality between 30 days and one year, 2) Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiac decompensation and 3) Prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic valve gradient > 20 mmHg or peak velocity > 3 m/s or moderate or severe prosthetic valve AR)	1 year