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) (NCT03326778)

Study 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.

Read the 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.

Conditions studied

Aortic Valve Stenosis
Coronary Artery Disease

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Keywords

Aortic Valve Stenosis
Rapid deployment Valve
CABG
Edwards Intuity Elite

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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.

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

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 220 participants (actual)
Target follow-up: 5 Years
Patient registry: Yes

Groups and cohorts

AVR + CABG
Patient receiving AVR combined with CABG
Procedure: AVR and CABG

Interventions

ProcedureAVR and CABG
Combined AVR with CABG

What researchers measure

Primary outcomes

all-cause mortality
death from any reason
Time frame: 30 Days

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03326778
Lead sponsor: Campus Bad Neustadt
Collaborators: Edwards Lifesciences, Software for Trials Europe GmbH, Institut für Pharmakologie und Präventive Medizin
Responsible party: Sponsor
First posted: Oct 31, 2017
Start date: Nov 26, 2017
Primary completion: Dec 6, 2019
Completion: Jul 1, 2020
Last update: Aug 26, 2021

Study contacts

Anno Diegeler, Prof.

principal investigator · Campus Bad Neustadt

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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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)