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)

Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis
• Intervention / Treatment: Procedure: AVR and CABG

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
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Bad Neustadt An Der Saale, Bavaria, Germany, 97616
      • Campus Bad Neustadt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AVR + CABG; Patient receiving AVR combined with CABG	Procedure: AVR and CABG; Combined AVR with CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	death from any reason	30 Days

Collaborators and Investigators

• Sponsor: Campus Bad Neustadt
• Collaborators: Institut für Pharmakologie und Präventive Medizin; Edwards Lifesciences; Software for Trials Europe GmbH
• Investigators: Principal Investigator: Anno Diegeler, Prof., Campus Bad Neustadt

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2017
• Primary Completion (ACTUAL): December 6, 2019
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (ACTUAL): October 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: CABG; Aortic Valve Stenosis; Rapid deployment Valve; Edwards Intuity Elite
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Coronary Artery Disease; Aortic Valve Stenosis
• Other Study ID Numbers: INCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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