Mitral Leaflet ProlapsePhase 2NCT01415947
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
A Phase 2 study testing V Chordal in people with Mitral Leaflet Prolapse, run by Edwards Lifesciences at 1 site in Italy.
Trial summary
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mitral Leaflet Prolapse
- What is being tested?
- V Chordal
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
- 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
- Inadequate echocardiographic window for transthoracic imaging
- 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.
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- Previously implanted annuloplasty ring/band.
- 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
1 site in 1 country.
About this study
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
- Conditions
- Mitral Leaflet Prolapse
- Being tested
- V Chordal
- Keywords
- Heart disease, Device, Mitral valve, leaflet prolapse, Heart valve disease, Cardiovascular disease, Neochordae
- Medical subject headings
- Mitral Valve Prolapse, 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.
V ChordalDevice
V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" . The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
ability to:
- Anchor the system in the papillary muscle;
- Suture the leaflet;
- Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue.
- Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB
Measured: 6 months
Efficacy
The ability of the V-Chordal System to correct leaflet prolapse of the treated segments as assessed by echordiography. Correction is defined as leaflet displacement <2 mm above the annulus in the septolateral view.
Measured: 30 days and 6 months
Secondary outcomes (1)
Incidence of Major Adverse Events (MAE).
Measured: 30 days, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionMar 2013
Why it stopped: Company business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Leaflet ProlapseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ottavio Alfiieri, MD, Principal investigator, Hospital San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415947
- Sponsor's protocol ID
- CH1-1
- Status last verified
- Dec 2014
- First submitted
- 10 Aug 2011
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
- ClinicalTrials.gov ID
- NCT01415947
- Acronym / sponsor ID
- CH1-1
- Conditions
- Mitral Leaflet Prolapse
- Keywords
- Heart disease, Device, Mitral valve, leaflet prolapse, Heart valve disease, Cardiovascular disease, Neochordae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company business decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Aug 2011 (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.
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
- 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 (12 listed)
- Inadequate echocardiographic window for transthoracic imaging
- 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
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 |
|---|---|---|
| V ChordalV-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" . The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords. | Device | – |
Primary outcome
Technical success rate
Time frame: 6 months
ability to: 1. Anchor the system in the papillary muscle; 2. Suture the leaflet; 3. Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue. 4. Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB
Efficacy
Time frame: 30 days and 6 months
The ability of the V-Chordal System to correct leaflet prolapse of the treated segments as assessed by echordiography. Correction is defined as leaflet displacement <2 mm above the annulus in the septolateral view.
1 secondary outcome
Incidence of Major Adverse Events (MAE).
Time frame: 30 days, and 6 months
Results and safety
The study was stopped early (reason given: Company business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
Ottavio Alfiieri, MD principal investigator
Hospital San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V Chordal in people with Mitral Leaflet Prolapse, run by Edwards Lifesciences at 1 site in Italy.
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 12 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 23 Dec 2014. 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 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.
What does this 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.
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: Company business decision). 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?
Technical success rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 23 Dec 2014.