Mitral Valve InsufficiencyREDUCE FMRNCT02325830
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
A study testing Carillon Mitral Contour System in people with Mitral Valve Insufficiency and Heart Failure, run by Cardiac Dimensions Pty Ltd at 31 sites in 8 countries.
Trial summary
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Valve Insufficiency, Heart Failure
- What is being tested?
- Carillon Mitral Contour System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 22 Aug 2015to 8 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dilated ischemic or non-ischemic cardiomyopathy
- Functional Mitral Regurgitation: 2+ (Moderate), 3+ (Moderate/Severe), or 4+ (Severe)
- New York Heart Association (NYHA) II, III, or IV
- Six Minute Walk distance of at least 150 meters and no farther than 450 meters
- Left Ventricular Ejection Fraction ≤ 50 %
- LV end diastolic dimension (LVEDD) >55mm or LVEDD/Body Surface Area (BSA) > 3.0cm/m2
- Stable heart failure medication regimen for at least three (3) months prior to index procedure
Who cannot join
- Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
- Hospitalization in the past 30 days for coronary angioplasty or stent placement
- Subjects expected to require any cardiac surgery within one (1) year
- Subjects expected to require any percutaneous coronary intervention within 30 days of enrollment
- Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV), or anticipated need for CRT within twelve (12) months
- Presence of a coronary artery stent under the CS / GCV in the implant target zone
Show all 10Show fewer
- Presence of left atrial appendage (LAA) clot.
- Presence of primary renal dysfunction or significantly compromised renal function as reflected by a serum creatinine > 2.2 mg/dL OR eGFR < 30 ml/min
- Inability to undertake a six-minute walk test due to physical restrictions/limitations
- Chronic severe pathology limiting survival to less than 12-months
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
Germany9 sites
Charité Universitätsmedizin Berlin
Berlin, 12203
Augusta Kranken-Anstalt GmbH
Bochum, 44791
Cardio Vascular Center Frankfurt
Frankfurt
Klinikum Frankfurt Höchst GmbH
Frankfurt
University Hospital Frankfurt
Frankfurt am Main
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau
Sana Kliniken Lübeck
Lübeck
Märkische Kliniken GmbH, Klinikum Lüdenscheid
Lüdenscheid, North Rhine-Westphalia, 58515
Elisabeth Krankenhaus GmbH
Recklinghausen, 45661
France7 sites
Hôpital Privé Saint-Martin
Caen, 14000
Pôle Sante République
Clermont-Ferrand, Auvergne
Clinique du Millénaire
Montpellier
European Hospital Georges Pompidou
Paris
Clinique Saint-Hilaire
Rouen, 76000
Hôpital Charles Nicolle
Rouen
CHU Rangueil
Toulouse, 31059
Australia6 sites
Flinders Medical Centre
Adelaide, South Australia, 5042
Prince Charles
Brisbane
Monash Health
Clayton, Victoria, 3168
Alfred Health
Prahran, Victoria, 3181
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Royal Prince Alfred
Sydney, New South Wales
Czechia3 sites
Olomouc University Hospital
Olomouc
Institut klinické a experimentální medicíny (IKEM)
Prague
Na Homolce Hospital
Prague
United Kingdom3 sites
Harefield Hospital
Harefield, Middlesex, UB9 6JH
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS2 9LN
Freeman Hospital
Newcastle upon Tyne
Netherlands1 site
Maastricht University Medical Centre
Maastricht, 6202 AZ
About this study
Official title: The REDUCE FMR Trial: Safety and Efficacy of the Carillon Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.
Read the detailed description
The American Heart Association (AHA) estimates that there are more than 22 million people worldwide with heart failure. Functional mitral regurgitation, defined as the leakage of the mitral valve caused by global or regional changes in left ventricular geometry as well as mitral annular dilation, occurs as a consequence of heart failure. Cardiac Dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner.
Cardiac Dimensions plans to conduct a clinical trial of the Carillon Mitral Contour System in study subjects with functional mitral regurgitation. This study is a prospective, randomized parallel-group, double-blind, multi-center clinical trial designed to examine the safety and efficacy of the Carillon Mitral Contour System in study subjects with functional mitral regurgitation. The study will consent up to 180 subjects in order to randomize up to 120 subjects at 25 investigational sites in Europe and Australia/New Zealand. Subjects will be randomized into one of two study groups using a 3:1 (Treatment group : Control group) ratio.
Study subjects who are eligible for this clinical study and have consented to participating in the study will undergo multiple assessments prior to randomization to evaluate the eligibility (inclusion/exclusion) criteria. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Treatment or Control).
Study subjects randomized to the Treatment group will undergo a venous angiogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant. If the subject meets the anatomic requirements for device placement, the Carillon implant procedure begins. With the distal aspect of the device anchored, incremental tension will be applied to plicate the peri-annular tissue. A transesophageal or transthoracic echocardiogram will be obtained during the procedure to evaluate the effect on functional mitral regurgitation and to evaluate left ventricular function. After the proximal anchor of the implant is locked in place, safety (including assessment of coronary arterial flow) and efficacy will be reconfirmed prior to releasing the Carillon implant from the delivery system.
Subjects randomized to the Control group will experience an index procedure similar to the Treatment group, however, without device placement. To ensure that subjects randomized to the Control group will not be able to deduce the treatment assignment based on the type of intervention or time associated with the procedure, minimal interventional procedures, such as femoral arterial pressure monitoring and a jugular venous drip. If a recent (within the last 3 months for ischemic cardiomyopathy or 12 months for non-ischemic cardiomyopathy) coronary angiogram is available, this assessment may be precluded.
After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), and twelve (12) months post-implant, to assess long-term safety, and functional and clinical status. (Reference Section 3.8-Study Follow-up Evaluations)
This study will provide for an independent Clinical Events Committee (CEC) and an independent Data Safety Monitoring Board (DSMB). The CEC will be responsible for adjudicating complications reported during the study that are related to study endpoints (objectives), the procedure or the device. The DSMB will review the safety data against the established criteria and in the context of other safety data accumulated to date and the continued validity of the study.
- Conditions
- Mitral Valve Insufficiency, Heart Failure
- Being tested
- Carillon Mitral Contour System
- Keywords
- Functional mitral regurgitation, Secondary mitral regurgitation, Percutaneous mitral repair
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carillon Mitral Contour SystemDevice
Percutaneous mitral valve repair
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Implantation of the Carillon Mitral Contour System Receives: Device: Carillon Mitral Contour System |
| Control Group | No intervention | Optimized stable medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months
The primary echocardiographic index and primary endpoint of the REDUCE FMR study was Regurgitant Volume (RV) in the ITT population (N=120). RV was analyzed for the ITT patient population calculated as the mean change per randomization group among subjects with evaluable data. Between group comparisons were performed using the Students' t-test.
Measured: Baseline and 12 months
Difference in the Rate of Major Adverse Events Between Treatment (Carillon) and Control Groups
Cumulative number of events for Death, Myocardial Infarction, Cardiac Perforation, Device embolization, and surgical or percutaneous intervention related to device.
Measured: Baseline and 12 months
Secondary outcomes (3)
Rate of Heart Failure Hospitalizations Between Treatment (Carillon) and Control Groups
A diagnosis of acute decompensated heart failure hospitalization (ADHF) requires an in-hospital stay that includes at least one calendar date change and requires intravenous or mechanical heart failure treatment. The length of hospital stay will be calculated from admission to discharge to home or other disposition.
The diagnosis of ADHF will be based on:
- Symptoms of worsening heart failure such as increased shortness of breath, orthopnea, paroxysmal nocturnal dyspnea, fatigue, decreased exercise tolerance or history of weight gain;
- Physical examination evidence such as neck vein distention, the presence of a third heart sound, bilateral pulmonary rales, worsening ascites or pedal edema, hypotension or signs of worsening end-organ perfusion; and/or
- Laboratory evidence, which may include pulmonary congestion on chest x-ray, elevated natriuretic peptide level, worsening oxygenation or respiratory acidosis.
Measured: Baseline and 12 months
Change in Six-minute Walk Distance Between Treatment (Carillon) and Control Groups
Subjects had 6-MWT conducted at baseline and each follow-up visit. The subject walked as far as they could within a 6-minute period. They were allowed to rest. The distance (in whole meters) was captured at each visit.
Measured: Baseline and 12 Months
Change in Left Ventricular Volumes Between Treatment (Carillon) and Control Groups
The volume of the left ventricle will be measured by a blinded echosonographer ajdn submitted to the core lab for blinded analysis. The ventricle will be measured as systole and diastole.
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study start22 Aug 2015
- Primary completion1 Jul 2018
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- With crossover for sham procedure patients who are eligible at time of 12 month follow up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiac Dimensions Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Menzies Institute for Medical Research
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, MD, Principal investigator, Cardio Vascular CenterDavid Kaye, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325830
- Sponsor's protocol ID
- CVP 1627-01
- Acronym
- REDUCE FMR
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2014
- Last updated
- 5 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.
PubMed 19597051Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.
PubMed 22613584Siminiak T, Hoppe UC, Schofer J, Haude M, Herrman JP, Vainer J, Firek L, Reuter DG, Goldberg SL, Van Bibber R. Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 2009 Aug 15;104(4):565-70. doi: 10.1016/j.amjcard.2009.04.021. Epub 2009 May 29.
PubMed 19660613Witte KK, Lipiecki J, Siminiak T, Meredith IT, Malkin CJ, Goldberg SL, Stark MA, von Bardeleben RS, Cremer PC, Jaber WA, Celermajer DS, Kaye DM, Sievert H. The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC Heart Fail. 2019 Nov;7(11):945-955. doi: 10.1016/j.jchf.2019.06.011. Epub 2019 Sep 11.
PubMed 31521683
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REDUCE FMR Trial: Safety and Efficacy of the Carillon Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure
- ClinicalTrials.gov ID
- NCT02325830
- Acronym / sponsor ID
- REDUCE FMR / CVP 1627-01
- Conditions
- Mitral Valve Insufficiency, Heart Failure
- Keywords
- Functional mitral regurgitation, Secondary mitral regurgitation, Percutaneous mitral repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Cardiac Dimensions Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Menzies Institute for Medical Research
- Study start
- 22 Aug 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.
Detailed description
The American Heart Association (AHA) estimates that there are more than 22 million people worldwide with heart failure. Functional mitral regurgitation, defined as the leakage of the mitral valve caused by global or regional changes in left ventricular geometry as well as mitral annular dilation, occurs as a consequence of heart failure. Cardiac Dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner.
Cardiac Dimensions plans to conduct a clinical trial of the Carillon Mitral Contour System in study subjects with functional mitral regurgitation. This study is a prospective, randomized parallel-group, double-blind, multi-center clinical trial designed to examine the safety and efficacy of the Carillon Mitral Contour System in study subjects with functional mitral regurgitation. The study will consent up to 180 subjects in order to randomize up to 120 subjects at 25 investigational sites in Europe and Australia/New Zealand. Subjects will be randomized into one of two study groups using a 3:1 (Treatment group : Control group) ratio.
Study subjects who are eligible for this clinical study and have consented to participating in the study will undergo multiple assessments prior to randomization to evaluate the eligibility (inclusion/exclusion) criteria. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Treatment or Control).
Study subjects randomized to the Treatment group will undergo a venous angiogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant. If the subject meets the anatomic requirements for device placement, the Carillon implant procedure begins. With the distal aspect of the device anchored, incremental tension will be applied to plicate the peri-annular tissue. A transesophageal or transthoracic echocardiogram will be obtained during the procedure to evaluate the effect on functional mitral regurgitation and to evaluate left ventricular function. After the proximal anchor of the implant is locked in place, safety (including assessment of coronary arterial flow) and efficacy will be reconfirmed prior to releasing the Carillon implant from the delivery system.
Subjects randomized to the Control group will experience an index procedure similar to the Treatment group, however, without device placement. To ensure that subjects randomized to the Control group will not be able to deduce the treatment assignment based on the type of intervention or time associated with the procedure, minimal interventional procedures, such as femoral arterial pressure monitoring and a jugular venous drip. If a recent (within the last 3 months for ischemic cardiomyopathy or 12 months for non-ischemic cardiomyopathy) coronary angiogram is available, this assessment may be precluded.
After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), and twelve (12) months post-implant, to assess long-term safety, and functional and clinical status. (Reference Section 3.8-Study Follow-up Evaluations)
This study will provide for an independent Clinical Events Committee (CEC) and an independent Data Safety Monitoring Board (DSMB). The CEC will be responsible for adjudicating complications reported during the study that are related to study endpoints (objectives), the procedure or the device. The DSMB will review the safety data against the established criteria and in the context of other safety data accumulated to date and the continued validity of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- With crossover for sham procedure patients who are eligible at time of 12 month follow up.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Carillon Mitral Contour SystemImplantation of the Carillon Mitral Contour System |
| Control Group | No intervention | –Optimized stable medical therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of dilated ischemic or non-ischemic cardiomyopathy
- Functional Mitral Regurgitation: 2+ (Moderate), 3+ (Moderate/Severe), or 4+ (Severe)
- New York Heart Association (NYHA) II, III, or IV
- Six Minute Walk distance of at least 150 meters and no farther than 450 meters
- Left Ventricular Ejection Fraction ≤ 50 %
Key exclusion criteria (10 listed)
- Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
- Hospitalization in the past 30 days for coronary angioplasty or stent placement
- Subjects expected to require any cardiac surgery within one (1) year
- Subjects expected to require any percutaneous coronary intervention within 30 days of enrollment
- Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV), or anticipated need for CRT within twelve (12) months
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 |
|---|---|---|
| Carillon Mitral Contour SystemPercutaneous mitral valve repair | Device | Treatment Group |
Primary outcome
Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months
Time frame: Baseline and 12 months
The primary echocardiographic index and primary endpoint of the REDUCE FMR study was Regurgitant Volume (RV) in the ITT population (N=120). RV was analyzed for the ITT patient population calculated as the mean change per randomization group among subjects with evaluable data. Between group comparisons were performed using the Students' t-test.
Difference in the Rate of Major Adverse Events Between Treatment (Carillon) and Control Groups
Time frame: Baseline and 12 months
Cumulative number of events for Death, Myocardial Infarction, Cardiac Perforation, Device embolization, and surgical or percutaneous intervention related to device.
3 secondary outcomes
Rate of Heart Failure Hospitalizations Between Treatment (Carillon) and Control Groups
Time frame: Baseline and 12 months
Change in Six-minute Walk Distance Between Treatment (Carillon) and Control Groups
Time frame: Baseline and 12 Months
Change in Left Ventricular Volumes Between Treatment (Carillon) and Control Groups
Time frame: Baseline and 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19597051Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.
- Background: PubMed 22613584Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.
- Background: PubMed 19660613Siminiak T, Hoppe UC, Schofer J, Haude M, Herrman JP, Vainer J, Firek L, Reuter DG, Goldberg SL, Van Bibber R. Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 2009 Aug 15;104(4):565-70. doi: 10.1016/j.amjcard.2009.04.021. Epub 2009 May 29.
- Derived from this study: PubMed 31521683Witte KK, Lipiecki J, Siminiak T, Meredith IT, Malkin CJ, Goldberg SL, Stark MA, von Bardeleben RS, Cremer PC, Jaber WA, Celermajer DS, Kaye DM, Sievert H. The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC Heart Fail. 2019 Nov;7(11):945-955. doi: 10.1016/j.jchf.2019.06.011. Epub 2019 Sep 11.
- Individual participant dataSharing planned: No
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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.
Horst Sievert, MD principal investigator
Cardio Vascular Center
David Kaye, MD principal investigator
The Alfred
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carillon Mitral Contour System in people with Mitral Valve Insufficiency and Heart Failure, run by Cardiac Dimensions Pty Ltd at 31 sites in 8 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 7 inclusion and 10 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, France, Australia, Czechia, United Kingdom and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months (time frame: Baseline and 12 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?
On the ClinicalTrials.gov record for NCT02325830, 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 Aug 2024.