EDWARDS INTUITY Valve System CADENCE-MIS Study

NCT02672553 | Completed Results

• 1 other identifier: 2011-12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease; Aortic Stenosis

Keywords

Aortic Valve Replacement; Minimal Invasive Sternotomy

Outcome Measures

Primary Outcomes (2)

• Median Subject Time Spent on Cardiopulmonary Cross Clamp

  Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.

  At time of surgery; an average of 1 hour

• Median Amount of Time Subject Spent on Cardiopulmonary Bypass

  Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

  At time of surgery; an average of 1 hour

Secondary Outcomes (26)

• Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.

  Baseline and 2 Years.

• Subject's Average Mean Gradients (mmHg) Measurements Over Time.

  Baseline, Discharge, 30 days, 3 Months, 1 Year

• Subject's Average Peak Gradients (mmHg) Measurements Over Time.

  Baseline, Discharge, 30 days, 3 Months, 1 Year

• Subject's Effective Orifice Area (EOA) Measurement Over Time.

  Baseline, Discharge, 30 days, 3 Months, 1 Year

• Amount of Paravalvular Leak Over Time.

  Discharge, 30 days, 3 month, 1 year

Study Arms (2)

EDWARDS INTUITY

ACTIVE COMPARATOR

EDWARDS INTUITY Valve System, Model 8300A

Device: EDWARDS INTUITY Valve System, Model 8300A

Stented Aortic Bioprostheses

ACTIVE COMPARATOR

Stented Aortic Bioprostheses

Device: Stented Aortic Bioprostheses

Interventions

EDWARDS INTUITY Valve System, Model 8300A DEVICE

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

Also known as: aortic stenosis, stenosis-based insufficiency, aortic valve replacement

EDWARDS INTUITY

Stented Aortic Bioprostheses DEVICE

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

Also known as: aortic stenosis, stenosis-based insufficiency, aortic valve replacement

Stented Aortic Bioprostheses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult male or female ≥18 years of age
• symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned
• EuroSCORE \<20
• NYHA Class ≥II
• Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed
• Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent
• pure aortic insufficiency
• previous cardiac surgery (involved FS or MIS approach)
• congenital true bicuspid / unicuspid aortic valve
• requires emergency surgery or has had emergency surgery for any reason
• ≤ 1 month before the intended treatment
• LVEF \<25%
• active endocarditis ≤ 6 months before the intended treatment
• acute MI ≤ 90 days before the intended treatment
• had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery

You may not qualify if:

• has calcium on the anterior mitral leaflet which cannot be removed
• has extensive calcification of the aortic root
• Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus
• has left atrial thrombus
• The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow
• hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system
• Study device is not available in the correct size for the subject

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

Leipzig Heart Center

Leipzig, Saxony, 04289, Germany

Location

Related Publications (2)

• 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.

  PMID: 26935407 RESULT

• 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.

  PMID: 25441065 RESULT

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mary Edwards, VP Clinical and Regulatory Affairs, HVT
• Organization: Edwards Lifesciences, LLC

mary_edwards@edwards.com

949-250-2500

Study Officials

• Prof. Borger, MD

  Leipzig Heart Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: February 3, 2016
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)