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CompletedNCT03259945ORVASUpdated Feb 9, 2026

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

An observational study in Patients With a Sutureless Aortic Valve, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
198
Sex
All
01

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.

02

Conditions studied

  • Patients With a Sutureless Aortic Valve
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with a pacemaker
  • patients who underwent double valve replacement
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
198 participants (actual)
Patient registry
No

Interventions

  • OtherData collection

    demographic and clinical data

  • OtherReview of ECGs

    nature and frequency of proven conduction disorders

05

What researchers measure

Primary outcomes

  1. presence of conduction disorders on postoperative ECGs

    Time frame: through study completion, an average of 2 years

06

Study locations

1 site
  • Chu Dijon Bourgogne
    Dijon, 21000, France
07

References and documents

Publications

  • Bouchot O, Petrosyan A, Morgant MC, Malapert G. Technical points for aortic valve replacement through right anterior minithoracotomy. Eur J Cardiothorac Surg. 2018 May 1;53(suppl_2):ii24-ii26. doi: 10.1093/ejcts/ezy105. PubMed 29718234 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03259945
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Feb 16, 2017
Primary completion
Dec 12, 2022
Completion
Dec 12, 2022
Last update
Feb 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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