Mitral Valve InsufficiencyNCT01137734
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation
A study testing Adjustable Annuloplasty Ring with option to adjust off pump. and Device: Adjustable Annuloplasty Ring (with option to adjust off-pump) in people with Mitral Valve Insufficiency, run by Edwards Lifesciences at 2 sites in 2 countries.
Trial summary
Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Adjustable Annuloplasty Ring with option to adjust off pump. and Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2010to Jan 2014
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a candidate for mitral valve repair.
- Patient able and willing to return to the implant center for follow-up visits.
- Able and willing to give informed consent and follow protocol procedures.
Who cannot join
- Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
- Evolving endocarditis or active endocarditis in the last 3 months.
- Heavily calcified annulus or leaflets.
- Congenital malformation with limited valvular tissue
- Patient requires mitral valve replacement.
- Previously implanted prosthetic mitral valve or annuloplasty ring/band.
Show all 11Show fewer
- Patient requires aortic or pulmonic valve replacement or repair.
- Patient is pregnant (urine HCG test result positive) or lactating.
- Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
- Life expectancy of less than twelve months.
- Patient is participating in concomitant research studies of investigational products
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair
Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Adjustable Annuloplasty Ring with option to adjust off pump., Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
- Keywords
- Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases
- Medical subject headings
- Mitral Valve Insufficiency, Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable Annuloplasty Ring with option to adjust off pump.Device
Also called Valtech Cardinal Adjustable ring
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty repair, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)Device
Evaluate the performance and safety of the investigational adjustable annuloplasty ring device for the treatment of mitral regurgitation, with option to adjust on and off-pump.
| Study group | Role | What they receive |
|---|---|---|
| Valtech Cardinal Mitral Annuloplasty Ring | Experimental | All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring. Receives: Device: Adjustable Annuloplasty Ring with option to adjust off pump.; Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success
Technical success of the implantation of the Cardinal Ring defined as the ability to size the annulus, place the sutures on the ring, lower the ring onto the valve, adjust the ring to the required size and disconnect the adjustment tool.
Measured: Day of surgery
Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring
The technical feasibility of "off cardiac bypass pump" adjustment during surgery, when required of the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Measured: Day of surgery
Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at the end of the procedure with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Measured: At the end of the procedure on the day of surgery compared to baseline.
Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at hospital discharge with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Measured: Day of discharge compared to baseline.
Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at 30 days with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Measured: 30 days compared to baseline.
Secondary outcomes (1)
Subject's Device Related Adverse Event Rate
The percentage of subjects that had a device related adverse event with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Vanermen, Prof, MD, Principal investigator, Hospital Onze-Lieve-Vrouw-Ziekenhuis, Aalst , BelgiumFredrich Mohr, Prof,MD, Principal investigator, University Leipzig, GermanyVolkmar Falk, Prof, MD, Principal investigator, University Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137734
- Sponsor's protocol ID
- VC1-1
- Status last verified
- Oct 2021
- First submitted
- 24 May 2010
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Publications
Si MS, Conte JV, Romano JC, Romano MA, Andersen ND, Gerdisch MW, Kupferschmid JP, Fiore AC, Bakhos M, Bonilla JJ, Burke JR, Rankin JS, Wei LM, Badhwar V, Turek JW. Unicuspid Aortic Valve Repair Using Geometric Ring Annuloplasty. Ann Thorac Surg. 2021 Apr;111(4):1359-1366. doi: 10.1016/j.athoracsur.2020.04.147. Epub 2020 Jun 30.
PubMed 32619617Czesla M, Gotte J, Voth V, Doll N. Single-Center Experience With Adjustable Annuloplasty Ring in Degenerative Mitral Regurgitation. Innovations (Phila). 2015 Jul-Aug;10(4):248-51; discussion 251. doi: 10.1097/IMI.0000000000000186.
PubMed 26371453Kolsut P, Juraszek A, Brzozowski P, Dabrowski M, Witkowski A, Rozanski J, Kusmierczyk M. Case report on successful 'bail out' aortic homograft implantation in a 81-year old woman with aortic ring rupture after double TAVI procedure. J Cardiothorac Surg. 2015 Mar 4;10:28. doi: 10.1186/s13019-015-0233-x.
PubMed 25887519Maisano F, Falk V, Borger MA, Vanermen H, Alfieri O, Seeburger J, Jacobs S, Mack M, Mohr FW. Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system. Eur J Cardiothorac Surg. 2013 Nov;44(5):913-8. doi: 10.1093/ejcts/ezt128. Epub 2013 Mar 25.
PubMed 23530026
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair
- ClinicalTrials.gov ID
- NCT01137734
- Acronym / sponsor ID
- VC1-1
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Jun 2010 (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.
Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valtech Cardinal Mitral Annuloplasty Ring | Experimental | Device: Adjustable Annuloplasty Ring with option to adjust off pump., Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is a candidate for mitral valve repair.
- Patient able and willing to return to the implant center for follow-up visits.
- Able and willing to give informed consent and follow protocol procedures.
Key exclusion criteria (11 listed)
- Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
- Evolving endocarditis or active endocarditis in the last 3 months.
- Heavily calcified annulus or leaflets.
- Congenital malformation with limited valvular tissue
- Patient requires mitral valve replacement.
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 |
|---|---|---|
| Adjustable Annuloplasty Ring with option to adjust off pump.Also: Valtech Cardinal Adjustable ringAnnuloplasty device repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty repair, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair. | Device | Valtech Cardinal Mitral Annuloplasty Ring |
| Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)Evaluate the performance and safety of the investigational adjustable annuloplasty ring device for the treatment of mitral regurgitation, with option to adjust on and off-pump. | Device | Valtech Cardinal Mitral Annuloplasty Ring |
Primary outcome
Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success
Time frame: Day of surgery
Technical success of the implantation of the Cardinal Ring defined as the ability to size the annulus, place the sutures on the ring, lower the ring onto the valve, adjust the ring to the required size and disconnect the adjustment tool.
Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring
Time frame: Day of surgery
The technical feasibility of "off cardiac bypass pump" adjustment during surgery, when required of the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline
Time frame: At the end of the procedure on the day of surgery compared to baseline.
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at the end of the procedure with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline
Time frame: Day of discharge compared to baseline.
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at hospital discharge with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline
Time frame: 30 days compared to baseline.
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at 30 days with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
1 secondary outcome
Subject's Device Related Adverse Event Rate
Time frame: 6 months
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 5 Nov 2021.
- Background: PubMed 32619617Si MS, Conte JV, Romano JC, Romano MA, Andersen ND, Gerdisch MW, Kupferschmid JP, Fiore AC, Bakhos M, Bonilla JJ, Burke JR, Rankin JS, Wei LM, Badhwar V, Turek JW. Unicuspid Aortic Valve Repair Using Geometric Ring Annuloplasty. Ann Thorac Surg. 2021 Apr;111(4):1359-1366. doi: 10.1016/j.athoracsur.2020.04.147. Epub 2020 Jun 30.
- Background: PubMed 26371453Czesla M, Gotte J, Voth V, Doll N. Single-Center Experience With Adjustable Annuloplasty Ring in Degenerative Mitral Regurgitation. Innovations (Phila). 2015 Jul-Aug;10(4):248-51; discussion 251. doi: 10.1097/IMI.0000000000000186.
- Background: PubMed 25887519Kolsut P, Juraszek A, Brzozowski P, Dabrowski M, Witkowski A, Rozanski J, Kusmierczyk M. Case report on successful 'bail out' aortic homograft implantation in a 81-year old woman with aortic ring rupture after double TAVI procedure. J Cardiothorac Surg. 2015 Mar 4;10:28. doi: 10.1186/s13019-015-0233-x.
- Background: PubMed 23530026Maisano F, Falk V, Borger MA, Vanermen H, Alfieri O, Seeburger J, Jacobs S, Mack M, Mohr FW. Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system. Eur J Cardiothorac Surg. 2013 Nov;44(5):913-8. doi: 10.1093/ejcts/ezt128. Epub 2013 Mar 25.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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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.
Hugo Vanermen, Prof, MD principal investigator
Hospital Onze-Lieve-Vrouw-Ziekenhuis, Aalst , Belgium
Fredrich Mohr, Prof,MD principal investigator
University Leipzig, Germany
Volkmar Falk, Prof, MD principal investigator
University Zurich, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable Annuloplasty Ring with option to adjust off pump. and Device: Adjustable Annuloplasty Ring (with option to adjust off-pump) in people with Mitral Valve Insufficiency, run by Edwards Lifesciences at 2 sites in 2 countries.
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 3 inclusion and 11 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Italy. 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.
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?
Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success (time frame: Day of surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01137734, which also lists 4 linked publications.
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 5 Nov 2021.