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Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

NCT03259945 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2026-02-09

No results posted yet for this study

Summary

The incidence of aortic valve disease is increasing steadily because of the ageing of the population. At a certain stage, replacement of the aortic valve improves symptoms and thus the quality of life of patients.

Surgical aortic valve replacement is the " gold standard ". The procedure involves stopping the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.

The reference technique consists in suturing a prosthetic valve to the aortic annulus so as to restore normal function. This technique has very good results in the long term. The elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of infection, psychological trauma of a major incision. In recent years an alternative approach, right minithoracotomy, has been proposed. The drawback to this approach is that it increases aortic cross-clamp time and CPB time.

More recently, new prosthetic valves, so-called "sutureless" or "rapid deployment" valves have become available. The main advantage of these valves is that they are easy to implant, as they do not require or need just a few sutures. As a result heart-arrest time is shorter, post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.

However, these valves have a metallic stent to fix the valve in place by pressing against the aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few studies have been conducted on this subject.

The investigators wish to evaluate these conduction disorders in a cohort of patients operated on in this Department with this sutureless or rapid deployment valve technique.

Conditions

  • Patients With a Sutureless Aortic Valve

Interventions

OTHER

Data collection

demographic and clinical data

OTHER

Review of ECGs

nature and frequency of proven conduction disorders

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-16
Primary Completion
2022-12-12
Completion
2022-12-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259945 on ClinicalTrials.gov