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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 (ORVAS)

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ClinicalTrials.gov Identifier: NCT03259945
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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.


Condition or disease Intervention/treatment
Patients With a Sutureless Aortic Valve Other: Data collection Other: Review of ECGs

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • Other: Data collection
    demographic and clinical data
  • Other: Review of ECGs
    nature and frequency of proven conduction disorders


Primary Outcome Measures :
  1. presence of conduction disorders on postoperative ECGs [ Time Frame: through study completion, an average of 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with a sutureless aortic valve implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU
Criteria

Inclusion Criteria:

All patients who underwent implantation of a Suturless valve since 2015 (Intuity Elite Edwards or Perceval S Liva Nova)

Exclusion Criteria:

  • patients with a pacemaker
  • patients who underwent double valve replacement

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): NCT03259945


Locations
France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Olivier BOUCHOT    0380293352    OLIVIER.BOUCHOT@CHU-DIJON.FR   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03259945     History of Changes
Other Study ID Numbers: BOUCHOT 2017
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No