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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 : Completed
First Posted : October 31, 2017
Last Update Posted : August 26, 2021
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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