EDWARDS INTUITY Valve System CADENCE-MIS Study

NCT ID: NCT02672553

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-08-31

Brief Summary

The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.

Detailed Description

This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore < 20 undergoing elective isolated aortic valve replacement (AVR) surgery.

Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.

Conditions

Aortic Valve Disease; Aortic Stenosis

Study Design

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

Study Groups

EDWARDS INTUITY

EDWARDS INTUITY Valve System, Model 8300A

Group Type: ACTIVE_COMPARATOR

EDWARDS INTUITY Valve System, Model 8300A

Intervention Type: DEVICE

To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.

Stented Aortic Bioprostheses

Stented Aortic Bioprostheses

Group Type: ACTIVE_COMPARATOR

Stented Aortic Bioprostheses

Intervention Type: DEVICE

In comparison to control valves available on the market undergoing FS-AVR

Interventions

EDWARDS INTUITY Valve System, Model 8300A

To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.

Intervention Type: DEVICE

Stented Aortic Bioprostheses

In comparison to control valves available on the market undergoing FS-AVR

Intervention Type: DEVICE

Other Intervention Names

aortic stenosis; stenosis-based insufficiency; aortic valve replacement; aortic stenosis; stenosis-based insufficiency; aortic valve replacement

Eligibility Criteria

Inclusion Criteria

1. adult male or female ≥18 years of age

2. symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned

3. EuroSCORE <20

4. NYHA Class ≥II

5. Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed

6. Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent

Exclusion (i.a.):

1. pure aortic insufficiency

2. previous cardiac surgery (involved FS or MIS approach)

3. congenital true bicuspid / unicuspid aortic valve

4. requires emergency surgery or has had emergency surgery for any reason

≤ 1 month before the intended treatment

5. LVEF <25%

6. active endocarditis ≤ 6 months before the intended treatment

7. acute MI ≤ 90 days before the intended treatment

8. had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery

9. oxygen or ventilator dependent

10. life expectancy < 12 months

11. substance abuser

12. Female subject is pregnant or lactating

13. documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy

14. hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure

15. documented echocardiographic evidence of intracardiac mass, thrombus or vegetation

16. renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis

17. documented hyperparathyroidism

18. currently participating in an investigational drug or device trial for which follow-up has not yet been completed

19. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition

Intra-operative Exclusion:

1. has calcium on the anterior mitral leaflet which cannot be removed

2. has extensive calcification of the aortic root

3. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus

4. has left atrial thrombus

5. The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow

6. hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system

7. Study device is not available in the correct size for the subject

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Borger, MD

Role: PRINCIPAL_INVESTIGATOR

Leipzig Heart Center

Locations

Leipzig Heart Center

Leipzig, Saxony, Germany

Countries

Germany

References

Borger MA, Dohmen PM, Knosalla C, Hammerschmidt R, Merk DR, Richter M, Doenst T, Conradi L, Treede H, Moustafine V, Holzhey DM, Duhay F, Strauch J. Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial. Eur J Cardiothorac Surg. 2016 Oct;50(4):713-720. doi: 10.1093/ejcts/ezw042. Epub 2016 Mar 2.

Reference Type: RESULT

PMID: 26935407 (View on PubMed)

Borger MA, Moustafine V, Conradi L, Knosalla C, Richter M, Merk DR, Doenst T, Hammerschmidt R, Treede H, Dohmen P, Strauch JT. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann Thorac Surg. 2015 Jan;99(1):17-25. doi: 10.1016/j.athoracsur.2014.09.022. Epub 2014 Nov 20.

Reference Type: RESULT

PMID: 25441065 (View on PubMed)

Other Identifiers

2011-12

Identifier Type: -

Identifier Source: org_study_id