Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG) (INCA)

• ClinicalTrials.gov Identifier: NCT03326778
• Recruitment Status: Completed
• First Posted: October 31, 2017
• Last Update Posted: August 26, 2021
• Sponsor: Campus Bad Neustadt
• Collaborators: Edwards Lifesciences; Software for Trials Europe GmbH; Institut für Pharmakologie und Präventive Medizin
• Information provided by (Responsible Party): Campus Bad Neustadt

Tracking Information

• First Submitted Date: October 27, 2017
• First Posted Date: October 31, 2017
• Last Update Posted Date: August 26, 2021
• Actual Study Start Date: November 26, 2017
• Actual Primary Completion Date: December 6, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2017)

all-cause mortality [ Time Frame: 30 Days ]

death from any reason

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)
• Official Title: Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
• Brief Summary: This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG). The registry will collect patient specific baseline data and established risk scores (Logistic Euroscore I & II, STS-Score, KBA Score) to enable us to make an estimate about the perioperative risks.

Detailed Description

Aortic replacement combined with coronary bypass surgery has an impact on the risk profile for the direct postoperative course and also on the long-time survival perspective.

The advantage of rapid deployment aortic valve prostheses, like the Edward Intuity Elite Valve that is used in this registry, is the greater ease of implantation, because only a few sutures are necessary to secure the device compared to a conventional prosthesis, where more then ten sutures are needed. In procedures where the aortic valve replacement (AVR) is combined with a coronary artery bypass graft (CABG), the use of a rapid deployment valve can shorten the duration of cardiac ischemia and the overall intervention duration, which possibly has an influence on clinical results.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with an indication for AVR combined with CABG who will receive an Edwards Intuity Elite rapid deployment aortic valve prosthesis.

Condition

• Aortic Valve Stenosis
• Coronary Artery Disease

Intervention

Procedure: AVR and CABG

Combined AVR with CABG

Study Groups/Cohorts

AVR + CABG

Patient receiving AVR combined with CABG

Intervention: Procedure: AVR and CABG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2021): 220
• Original Estimated Enrollment (submitted: October 27, 2017): 750
• Actual Study Completion Date: July 1, 2020
• Actual Primary Completion Date: December 6, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Inclusion Criteria:
• patients with aortic valve stenosis and coronary heart disease with indication for AVR and CABG
• patients in who the Edwards Intuity Elite valve is to be implanted
• patients who are planned to receive at least one coronary bypass
• patients who have signed an informed consent form

Exclusion Criteria:

• Exclusion Criteria:
• emergency surgery
• re-operation (i.e. any previous opening of pericardium)
• additional heart diseases requiring heart surgery (e. g. subvalvular myectomy and ablation, but not atrial auricle closure or resection)
• legal incapacity or other circumstances that impair the patient's ability to understand the nature, meaning or extent of the trial
• patients wanting a mechanical prosthesis
• patients with contraindications for the Edwards Intuity Elite Valve
• acute endocarditis or other systemic infections

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03326778
• Other Study ID Numbers: INCA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Campus Bad Neustadt
• Study Sponsor: Campus Bad Neustadt

Collaborators

• Edwards Lifesciences
• Software for Trials Europe GmbH
• Institut für Pharmakologie und Präventive Medizin

Investigators

• Principal Investigator: Anno Diegeler, Prof.; Campus Bad Neustadt

• PRS Account: Campus Bad Neustadt
• Verification Date: August 2021