Mitral Valve InsufficiencyPhase 4HiRiDeNCT02534155
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy
A Phase 4 study testing MitraClip® and Mitral valve Surgery in people with Mitral Valve Insufficiency, run by University of Zurich at 12 sites in 3 countries.
Trial summary
The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs. surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or Surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- MitraClip® and Mitral valve Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Apr 2015to Sep 2018
- Phase
- Phase 4
- 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
- Gender: Both, male and female
- Minimum Age: 18 Years
- Maximum Age: no maximum age
- Severe (4+) DMR (degenerative mitral regurgitation), or 3+ DMR
- NYHA Functional Class III or IV
- Mitral valve anatomy should be suitable for both MitraClip® and Mitral valve surgery (repair or replacement)
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- Subjects meet the following conditions:
- Age >18 and high or intermediate risk patients with an STS calculated mortality (using the repair calculator) >=3% and <=10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors
- patient is operable
- Signed by the subject and dated approved informed consent prior to any study related procedure
- Available and able to return to study site for post-procedural follow-up examination
Who cannot join
- Patient incapable to approve the informed consent or Emergency Cases
- functional mitral valve pathology
- evolving endocarditis or active endocarditis in the last 3 months
- heavily calcified leaflets
- subjects in whom transesophageal echocardiography is contraindicated
- subjects in whom transseptal catheterisation is contraindicated
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- presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year
- currently participating in the study of an investigational drug or device
- untreated clinically significant CAD requiring revascularisation
- any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
- prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- concomitant and significant aortic or tricuspid valve pathology
- CVA or TIA within 6 months or severe carotid stenosis (>70% assessed by Ultrasound)
- contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately managed with premedication
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Germany6 sites
Universitätsklinikum Bonn
Bonn, 53127
Universitätsklinikum Köln, Herzzentrum
Cologne, 50937
Asklepios Klinik Hamburg St. Georg
Hamburg, 20099
Universitäres Herzzentrum Hamburg GmbH
Hamburg, 20246
Klinikum der Universität München Großhadern
München, 81377
Helios Klinikum Siegburg
Siegburg, 53721
Italy3 sites
Presidio Ospedaliero Ferrarotto Alessi
Catania, 95124
San Raffaele Hospital
Milan, 20132
Policlinico Tor Vergata
Roma, 00133
Switzerland3 sites
Inselspital Bern
Bern, 3010
Fondazione Cardiocentro Ticino
Lugano, 6900
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091
About this study
Official title: High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy
The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs. surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12 months post-procedure).
Read the detailed description
Two-arm, multi-centre, randomised prospective study comparing MitraClip® to Surgical therapy in high and intermediate risk patients. Patients should be older than 18 years and high and intermediate risk is defined by a score (for MV repair) >= 3% and <= 10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors. Patients are selected upon clinical conditions and severity of MR. Anatomical feasibility is assessed by ECHO, according to the IFU (information for use).
The purpose of the trial is to evaluate safety and efficacy of MitraClip® vs. surgery in high and intermediate risk patients with DMR. Study Follow-Up includes the following visits after procedure: Hospital discharge, 1, 6, 12 months post-procedure.
Primary Endpoints are the 30-day safety superiority (ITT analysis) and the 12-month efficacy non-inferiority (ITT analysis) of the MitraClip®. The overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) until 12 months and the MR Severity reduction at 6 and 12 month in the MitraClip® and Surgery groups are Secondary Endpoints
- Conditions
- Mitral Valve Insufficiency
- Being tested
- MitraClip®, Mitral valve Surgery
- Keywords
- MitraClip®, MR, DMR, high-risk patients, mitral regurgitation, surgery, intermediate risk patients
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip®Device
one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory
Mitral valve SurgeryProcedure or surgery
Repair or replace mitral valve
| Study group | Role | What they receive |
|---|---|---|
| MitraClip® Therapy | Active comparator | MitraClip® system is a CE marked medical device, which consists of two parts (Clip Delivery System and Steerable Guide Catheter). It is a single sized, percutaneously implanted mechanical Clip. The MitraClip® device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The procedure is performed in the cardiac catheterisation laboratory with echocardiographic and fluoroscopic guidance while the patient is under general anaesthesia. Receives: Device: MitraClip® |
| Surgery | Active comparator | Surgical therapy of degenerative mitral regurgitation: repair or replacement of mitral valve, clinical standard Receives: Procedure: Mitral valve Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day safety superiority (ITT analysis): Major Adverse Event Composite
The study is powered to show superiority for safety of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary safety endpoint is a Major Adverse Event Composite (MAE) including all-cause death, prolonged ventilation (>48h), renal failure, stroke and need for non-elective cardiovascular or thoracic surgery (defined as any kind of cardiovascular and thoracic surgery performed within 30 days from the index procedure and non anticipated prior to the procedure). The analysis of the primary safety endpoint is a test of superiority for the proportion of subjects free from the composite of safety events in the Device vs. the Surgery group at 30 days.
Measured: 30 days
12-month efficacy non-inferiority (ITT analysis): Proportion of responders in the Device vs. the Surgery group
The study is powered to show non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary effectiveness endpoint is a test of non-inferiority for the proportion of responders in the Device vs. the Surgery group at 12 months. Patients are defined as responders if they are alive with at least a 1-grade improvement in NYHA Functional Class at 12 months over baseline and have not experienced a HF hospitalization within 12 months of randomization (MitraClip® procedure or Surgery).
Measured: 12 month
Secondary outcomes (9)
Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month
Evaluation of all SAEs and SADEs that occur during the trial
Measured: 12 month
MR Severity reduction at 6 and 12 month
MR (Mitral Regurgitation) Severity reduction at 6 and 12 months in the MitraClip® and Surgery groups
Measured: between 6 and 12 month
NYHA class changes at 6 and 12 months
NYHA class changes at 6 and 12 months in the MitraClip® and Surgery groups
Measured: between 6 and 12 month
Change in 6MWT in 6 and 12 month
Change in 6MWT (6 Minute Walking Test) in 6 and 12 months in the MitraClip® and Surgery groups
Measured: between 6 and 12 months
Change in Quality of Life in 6 and 12 months
Change in Quality of Life (MLWHF) at 1,6 and 12 month in the MitraClip® and Surgery groups
Measured: between 1 and 12 months
Heart failure hospitalisation rate
Heart failure hospitalisation rate in the post randomisation in the MitraClip® and Surgery groups
Measured: during 12 months post procedure
Days alive and out of hospital
Days alive and out of hospital in the 12 months post-randomisation in the MitraClip® and Surgery groups
Measured: during 12 months post procedure
Hospital resources utilisations
Hospital resources utillizations: length of stay post-procedure, ICU beds occupancy, need for rehabilitation services
Measured: during 12 months post procedure
Change in Quality of Life (SF36) in 6 and 12 months
Change in SF36 at 1,6 and 12 month in the MitraClip® and Surgery groups
Measured: between 1 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 posted27 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Maisano, Prof., Principal investigator, Universitätspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534155
- Sponsor's protocol ID
- HiRiDe
- Acronym
- HiRiDe
- Status last verified
- Sep 2016
- First submitted
- 6 Aug 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy
- ClinicalTrials.gov ID
- NCT02534155
- Acronym / sponsor ID
- HiRiDe / HiRiDe
- Conditions
- Mitral Valve Insufficiency
- Keywords
- MitraClip®, MR, DMR, high-risk patients, mitral regurgitation, surgery, intermediate risk patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Aug 2015 (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 study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs. surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12 months post-procedure).
Detailed description
Two-arm, multi-centre, randomised prospective study comparing MitraClip® to Surgical therapy in high and intermediate risk patients. Patients should be older than 18 years and high and intermediate risk is defined by a score (for MV repair) >= 3% and <= 10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors. Patients are selected upon clinical conditions and severity of MR. Anatomical feasibility is assessed by ECHO, according to the IFU (information for use).
The purpose of the trial is to evaluate safety and efficacy of MitraClip® vs. surgery in high and intermediate risk patients with DMR. Study Follow-Up includes the following visits after procedure: Hospital discharge, 1, 6, 12 months post-procedure.
Primary Endpoints are the 30-day safety superiority (ITT analysis) and the 12-month efficacy non-inferiority (ITT analysis) of the MitraClip®. The overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) until 12 months and the MR Severity reduction at 6 and 12 month in the MitraClip® and Surgery groups are Secondary Endpoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitraClip® Therapy | Active comparator | Device: MitraClip®MitraClip® system is a CE marked medical device, which consists of two parts (Clip Delivery System and Steerable Guide Catheter). It is a single sized, percutaneously implanted mechanical Clip. The MitraClip® device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The procedure is performed in the cardiac catheterisation laboratory with echocardiographic and fluoroscopic guidance while the patient is under general anaesthesia. |
| Surgery | Active comparator | Procedure: Mitral valve SurgerySurgical therapy of degenerative mitral regurgitation: repair or replacement of mitral valve, clinical standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Gender: Both, male and female
- Minimum Age: 18 Years
- Maximum Age: no maximum age
- Severe (4+) DMR (degenerative mitral regurgitation), or 3+ DMR
- NYHA Functional Class III or IV
Key exclusion criteria (14 listed)
- Patient incapable to approve the informed consent or Emergency Cases
- functional mitral valve pathology
- evolving endocarditis or active endocarditis in the last 3 months
- heavily calcified leaflets
- subjects in whom transesophageal echocardiography is contraindicated
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 |
|---|---|---|
| MitraClip®one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory | Device | MitraClip® Therapy |
| Mitral valve SurgeryRepair or replace mitral valve | Procedure or surgery | Surgery |
Primary outcome
30-day safety superiority (ITT analysis): Major Adverse Event Composite
Time frame: 30 days
The study is powered to show superiority for safety of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary safety endpoint is a Major Adverse Event Composite (MAE) including all-cause death, prolonged ventilation (>48h), renal failure, stroke and need for non-elective cardiovascular or thoracic surgery (defined as any kind of cardiovascular and thoracic surgery performed within 30 days from the index procedure and non anticipated prior to the procedure). The analysis of the primary safety endpoint is a test of superiority for the proportion of subjects free from the composite of safety events in the Device vs. the Surgery group at 30 days.
12-month efficacy non-inferiority (ITT analysis): Proportion of responders in the Device vs. the Surgery group
Time frame: 12 month
The study is powered to show non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary effectiveness endpoint is a test of non-inferiority for the proportion of responders in the Device vs. the Surgery group at 12 months. Patients are defined as responders if they are alive with at least a 1-grade improvement in NYHA Functional Class at 12 months over baseline and have not experienced a HF hospitalization within 12 months of randomization (MitraClip® procedure or Surgery).
9 secondary outcomes
Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month
Time frame: 12 month
MR Severity reduction at 6 and 12 month
Time frame: between 6 and 12 month
NYHA class changes at 6 and 12 months
Time frame: between 6 and 12 month
Change in 6MWT in 6 and 12 month
Time frame: between 6 and 12 months
Change in Quality of Life in 6 and 12 months
Time frame: between 1 and 12 months
Heart failure hospitalisation rate
Time frame: during 12 months post procedure
Days alive and out of hospital
Time frame: during 12 months post procedure
Hospital resources utilisations
Time frame: during 12 months post procedure
Change in Quality of Life (SF36) in 6 and 12 months
Time frame: between 1 and 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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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.
Francesco Maisano, Prof. principal investigator
Universitätspital Zürich
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MitraClip® and Mitral valve Surgery in people with Mitral Valve Insufficiency, run by University of Zurich at 12 sites in 3 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 11 inclusion and 14 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Italy, Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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. 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?
30-day safety superiority (ITT analysis): Major Adverse Event Composite (time frame: 30 days). 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 9 Sep 2016.