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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-26

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)

NCT03570190

Aortic Valve Stenosis

COMPLETED

Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access

NCT03056573

Aortic Valve Stenosis

COMPLETED NA

EDWARDS INTUITY Valve System FOUNDATION Study

NCT02338154

Aortic Valve Disease Aortic Stenosis Rapid Deployment Valves

COMPLETED

The ReTAVI Prospective Observational Registry

NCT05601453

Structural Valve Deterioration Structural Valve Degeneration Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure +2 more

RECRUITING

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

NCT06777368

Aortic Stenosis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AVR + CABG

Patient receiving AVR combined with CABG

AVR and CABG

Intervention Type PROCEDURE

Combined AVR with CABG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AVR and CABG

Combined AVR with CABG

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No