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Newer, faster heart valve surgery may cause hidden rhythm issues

NCT ID NCT03259945

Knowledge-focused Sponsor: Centre Hospitalier Universitaire Dijon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked back at 198 patients who had a sutureless aortic valve replacement to see how often they developed heart rhythm problems. These newer valves are faster to implant but have a metal frame that might affect the heart's electrical system. The goal was to better understand these risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

198 people

The number who actually took part.

Started

Feb 2017

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

patients with a sutureless aortic valve implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patients with A sutureless aortic valve

Contacts and locations

Locations

  • Chu Dijon Bourgogne

    Dijon, 21000, France

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