Heart Valve DiseasesPhase 2/3NCT00221663
Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
A Phase 2/3 study testing surgery techniques (sternotomy for aortic valve replacement) in people with Heart Valve Diseases, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- surgery techniques (sternotomy for aortic valve replacement)
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Dec 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of isolated aortic valvular replacement
- Preoperative ASA class < = 3
- Left ventricular ejection fraction > = 40%
- Signed informed consent
Who cannot join
- Aortic or mitral insufficiency > 3
- History of cardiac surgery
- Acute pulmonary edema
- Endocarditis
- Chronic renal insufficiency decompensation
- Operative coagulation disorders regardless of etiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults
Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.
Read the detailed description
Background:
Minimally invasive techniques for cardiac surgery should be formally evaluated.
Design:
Randomized, single-blind, monocentric trial.
Interventions Compared:
Median sternotomy versus minimally invasive technique.
Eligibility Criteria:
Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class < = 3, left ventricular ejection fraction > = 40%.
Primary Outcome:
Forced expiratory volume and peak expiratory volume/second at 48 hours.
- Conditions
- Heart Valve Diseases
- Being tested
- surgery techniques (sternotomy for aortic valve replacement)
- Keywords
- Cardiac surgery, Aortic valve replacement, Minimally invasive surgery, Perioperative course
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery techniques (sternotomy for aortic valve replacement)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume and peak expiratory volume/second
Measured: at 48 hours
Secondary outcomes (8)
Forced expiratory volume
Measured: at 24 hours
Peak expiratory volume/s at 24 hours
Pro-inflammatory cytokines on tracheal aspiration samples
Transfusion requirements during the first 24 hours post operative
Hemodynamic parameters
Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
Consumption of analgetics
Morbidity and mortality during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionJan 2002
- Study completionDec 2006
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Gerard Janvier, Pr, Principal investigator, University Hospital, BordeauxJoachim Calderon, Dr, Principal investigator, University Hospital, Bordeaux FranceGeneviéve Chene, Pr, Study chair, University Hospital, Bordeaux France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221663
- Sponsor's protocol ID
- 7945-00
- Other IDs
- 2000-05
- Status last verified
- Aug 2008
- First submitted
- 13 Sep 2005
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults
- ClinicalTrials.gov ID
- NCT00221663
- Acronym / sponsor ID
- 7945-00
- Conditions
- Heart Valve Diseases
- Keywords
- Cardiac surgery, Aortic valve replacement, Minimally invasive surgery, Perioperative course
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2002
- Primary completion
- Jan 2002 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.
Detailed description
Background:
Minimally invasive techniques for cardiac surgery should be formally evaluated.
Design:
Randomized, single-blind, monocentric trial.
Interventions Compared:
Median sternotomy versus minimally invasive technique.
Eligibility Criteria:
Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class < = 3, left ventricular ejection fraction > = 40%.
Primary Outcome:
Forced expiratory volume and peak expiratory volume/second at 48 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication of isolated aortic valvular replacement
- Preoperative ASA class < = 3
- Left ventricular ejection fraction > = 40%
- Signed informed consent
Key exclusion criteria (6 listed)
- Aortic or mitral insufficiency > 3
- History of cardiac surgery
- Acute pulmonary edema
- Endocarditis
- Chronic renal insufficiency decompensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery techniques (sternotomy for aortic valve replacement) | Device | – |
Primary outcome
Forced expiratory volume and peak expiratory volume/second
Time frame: at 48 hours
8 secondary outcomes
Forced expiratory volume
Time frame: at 24 hours
Peak expiratory volume/s at 24 hours
Pro-inflammatory cytokines on tracheal aspiration samples
Transfusion requirements during the first 24 hours post operative
Hemodynamic parameters
Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
Consumption of analgetics
Morbidity and mortality during hospital stay
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Janvier, Pr principal investigator
University Hospital, Bordeaux
Joachim Calderon, Dr principal investigator
University Hospital, Bordeaux France
Geneviéve Chene, Pr study chair
University Hospital, Bordeaux France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing surgery techniques (sternotomy for aortic valve replacement) in people with Heart Valve Diseases, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume and peak expiratory volume/second (time frame: at 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2008; AzTrials last refreshed its copy on 26 Oct 2026.