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OpenTrials
Completed

NCT Number: NCT03326778

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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Campus Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVR and CABG

Procedure

Combined AVR with CABG

Primary outcomes

  1. all-cause mortality

    Time frame: 30 Days

    death from any reason

Sponsors and collaborators

Lead sponsor

Campus Bad Neustadt

Other

Collaborators

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

Registry information

Official study title

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

Acronym: INCA

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 31, 2017
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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