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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)

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ClinicalTrials.gov Identifier: NCT03326778
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborators:
Edwards Lifesciences
Software for Trials Europe GmbH
Institut für Pharmakologie und Präventive Medizin
Information provided by (Responsible Party):
Campus Bad Neustadt

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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Coronary Artery Disease 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
Actual Study Start Date : November 26, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: 30 Days ]
    death from any reason



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326778


Contacts
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Contact: Anno Diegeler, Prof. +49-(0)9771 ext 662416 cachir@herzchirurgie.de
Contact: Monika Back +49-(0)9771 ext 662613 monika.back@herzchirurgie.de

Locations
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Germany
Campus Bad Neustadt Recruiting
Bad Neustadt An Der Saale, Bavaria, Germany, 97616
Contact: Anno Diegeler, Prof    09771-66-2416      
Contact: Monika Back    09771-66-2613    monika.back@herzchirurgie.de   
Sub-Investigator: Aris Lenos, MD         
Sponsors and Collaborators
Campus Bad Neustadt
Edwards Lifesciences
Software for Trials Europe GmbH
Institut für Pharmakologie und Präventive Medizin
Investigators
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Principal Investigator: Anno Diegeler, Prof. Campus Bad Neustadt

Additional Information:

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Responsible Party: Campus Bad Neustadt
ClinicalTrials.gov Identifier: NCT03326778     History of Changes
Other Study ID Numbers: INCA
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Campus Bad Neustadt:
Aortic Valve Stenosis
Rapid deployment Valve
CABG
Edwards Intuity Elite
Additional relevant MeSH terms:
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Coronary Artery Disease
Aortic Valve Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction