Heart Valve DiseasesNCT03664102
Automated Fastener Device Versus Manually Tied Knot in MiAVR
An observational study of Heart Valve Diseases, run by Centre Hospitalier La Chartreuse.
Trial summary
The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT). Four hundred and forty patients were operated for AVR by RAMT. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Cor Knot
- Type of treatment
- Medical device
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2009to 6 Sep 2018
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient operated on an Isolated aortic valve replacement with stented prosthesis by Minimally-invasive approach (right anterior minithoracotomy)
Who may be able to join
- age > 18 years
- Elective patient
- Isolated aortic valve replacement with stented prosthesis
- Minimally-invasive approach (right anterior minithoracotomy)
Who cannot join
- Associated procedure
- Aortic valve replacement with sutureless or rapid valve deployment prosthesis
- Active endocarditis
- Prior cardiac surgery
About this study
Official title: Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery
The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).
Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.
The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.
- Conditions
- Heart Valve Diseases
- Being tested
- Cor Knot
- 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.
Cor KnotDevice
Heart valve replacement with or without the use of automated fastener device Cor Knot
| Study group | Role | What they receive |
|---|---|---|
| Sutures with hand-tied knots | Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots | |
| Sutures with automated fastener device (Cor-Knot) | Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot) Receives: Device: Cor Knot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac surgery times
Aortic cross-clamping and cardiopulmonary bypass times
Measured: peroperative data
Secondary outcomes (1)
Morbimortality
Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation
Measured: Perioperative (30 days) and 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Sep 2009
- Primary completion1 Sep 2018
- Study completion6 Sep 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier La Chartreuse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664102
- Sponsor's protocol ID
- CCVT-MORGANT 082018
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Trial on medical records only. No specific regulatory authorization required. The trial has already been recorded as Professionnal evaluation practices.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT03664102
- Acronym / sponsor ID
- CCVT-MORGANT 082018
- Conditions
- Heart Valve Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Centre Hospitalier La ChartreuseUniversity, hospital or other
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 10 Sep 2018 (actual)
- 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.
The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).
Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.
The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sutures with hand-tied knots | – | –Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots |
| Sutures with automated fastener device (Cor-Knot) | – | Device: Cor KnotMinimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient operated on an Isolated aortic valve replacement with stented prosthesis by Minimally-invasive approach (right anterior minithoracotomy)
Key inclusion criteria (4 listed)
- age > 18 years
- Elective patient
- Isolated aortic valve replacement with stented prosthesis
- Minimally-invasive approach (right anterior minithoracotomy)
Key exclusion criteria (4 listed)
- Associated procedure
- Aortic valve replacement with sutureless or rapid valve deployment prosthesis
- Active endocarditis
- Prior cardiac surgery
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 |
|---|---|---|
| Cor KnotHeart valve replacement with or without the use of automated fastener device Cor Knot | Device | Sutures with automated fastener device (Cor-Knot) |
Primary outcome
Cardiac surgery times
Time frame: peroperative data
Aortic cross-clamping and cardiopulmonary bypass times
1 secondary outcome
Morbimortality
Time frame: Perioperative (30 days) and 24 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No. Trial on medical records only. No specific regulatory authorization required. The trial has already been recorded as Professionnal evaluation practices.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases, run by Centre Hospitalier La Chartreuse.
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 4 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: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac surgery times (time frame: peroperative data). 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 10 Sep 2018.