Mitral RegurgitationPhase 4ISAR-CLIPNCT01431222
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
A Phase 4 study testing percutaneous treatment by implanting a Mitra Clip device in people with Mitral Regurgitation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- percutaneous treatment by implanting a Mitra Clip device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Sep 2014
- 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
- age ≥ 18 years
- signed written consent
- symptomatic patients (NYHA-stadium ≥ III) for at least 3 months with an exploited medical heart insufficiency therapy
- increased perioperative risk with a logistic EuroScore ≥ 15 or STS-Score ≥ 15
- MR grade ≥ 2, amenable for MitraClip intervention assessed by an experienced interventional cardiologist
- Affirmation of in-operability by a "Heart-Team" consisting of either 1 cardiac surgeon and 1 cardiologist or 3 cardiologists
Who cannot join
- one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation
- implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months
- solid tumor with a live expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsches Herzzentrum Muenchen
Munich, Bavaria, 80636
Joerg Hausleiter, MD, +49-89-1218-0 ext. 4018, hausleiter@dhm.mhn.de
Hasema Lesevic, MD, +49-89-1218-0, lesevic@dhm.mhn.de
About this study
Official title: Interventional Strategy to Abrogate Mitral Regurgitation Using the MitraClip System in High-Risk Patients Considered Unsuitable for Surgery (ISAR-CLIP)
The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.
Read the detailed description
The presence of a significant mitral regurgitation (MR) seriously effects the patient's quality of life and is associated with an increased mortality rate. The operative treatment of MR - either mitral valve repair or replacement - is the current gold standard. However mere half of the patients with a severe and symptomatic MR actually undergo an operative treatment (EURO-HEART-SURVEY) due to restricted left ventricular ejection fraction, elderly patients with co-morbidities and high perioperative morbidity and mortality. In contrast, patients with severe and symptomatic MR not suitable for operation are treated with palliative medical therapy (heart insufficiency therapy). With the development of the MitraClip device - a minimal-invasive, percutaneous catheter-based technique - high-risk patients not suitable for surgery may receive a promising alternative treatment by approximating the mitral leaflets, thus creating a permanent leaflet coaptation and reducing or even abrogating the MR. The current data support the assumption of a safe and effective MR reduction with the MitraClip-System in inoperable high-risk patients with severe MR. But the feasibility still has to be proven in this special patient population.
- Conditions
- Mitral Regurgitation
- Being tested
- percutaneous treatment by implanting a Mitra Clip device
- Keywords
- severe mitral regurgitation, interventional mitral valve reconstruction, inoperable, EuroSCORE, STS Risk Score, MitraClip, fluoroscopy, echocardiography, percutaneous treatment of mitral regurgitation
- 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.
percutaneous treatment by implanting a Mitra Clip deviceDevice
Also called Mitra Clip system
With a minimal-invasive, percutaneous catheter-based technique and trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance, the MitraClip device grasps and approximates the mitral leaflets thus creating a double-orifice mitral valve with a permanent leaflet coaptation and a reduction or even abrogation of mitral regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous treatment | Active comparator | Not described Receives: Device: percutaneous treatment by implanting a Mitra Clip device |
| optimal medical treatment | No intervention | Not described Receives: Device: percutaneous treatment by implanting a Mitra Clip device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Dyspnoea of at least one class (NYHA-Classification)
Measured: after 6 months
Secondary outcomes (1)
composite endpoint and clinical outcome measured by NYHA-classification
- composite endpoint (death of any cause, myocardial infarction, stroke, sepsis, TIMI major bleeding, clip embolisation, partial clip detachement, acute renal failure)
- unscheduled hospitalization due to increased heart insuffiecency
- changes in quality of life
- echocardiographic parameters
- loboratory parameters
- resiliance measured by spiroergometry
Measured: 1 year and 2 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Joerg Hausleiter, MD, Study chair, Deutsches Herzzentrum MuenchenSteffen Massberg, MD, Principal investigator, Deutsches Herzzentrum MuenchenJuergen Pache, MD, Principal investigator, Deutsches Herzzentrum MuenchenHasema Lesevic, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431222
- Sponsor's protocol ID
- IsarClip
- Acronym
- ISAR-CLIP
- Status last verified
- Sep 2011
- First submitted
- 7 Sep 2011
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Strategy to Abrogate Mitral Regurgitation Using the MitraClip System in High-Risk Patients Considered Unsuitable for Surgery (ISAR-CLIP)
- ClinicalTrials.gov ID
- NCT01431222
- Acronym / sponsor ID
- ISAR-CLIP / IsarClip
- Conditions
- Mitral Regurgitation
- Keywords
- severe mitral regurgitation, interventional mitral valve reconstruction, inoperable, EuroSCORE, STS Risk Score, MitraClip, fluoroscopy, echocardiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 9 Sep 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 primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.
Detailed description
The presence of a significant mitral regurgitation (MR) seriously effects the patient's quality of life and is associated with an increased mortality rate. The operative treatment of MR - either mitral valve repair or replacement - is the current gold standard. However mere half of the patients with a severe and symptomatic MR actually undergo an operative treatment (EURO-HEART-SURVEY) due to restricted left ventricular ejection fraction, elderly patients with co-morbidities and high perioperative morbidity and mortality. In contrast, patients with severe and symptomatic MR not suitable for operation are treated with palliative medical therapy (heart insufficiency therapy). With the development of the MitraClip device - a minimal-invasive, percutaneous catheter-based technique - high-risk patients not suitable for surgery may receive a promising alternative treatment by approximating the mitral leaflets, thus creating a permanent leaflet coaptation and reducing or even abrogating the MR. The current data support the assumption of a safe and effective MR reduction with the MitraClip-System in inoperable high-risk patients with severe MR. But the feasibility still has to be proven in this special patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous treatment | Active comparator | Device: percutaneous treatment by implanting a Mitra Clip device |
| optimal medical treatment | No intervention | Device: percutaneous treatment by implanting a Mitra Clip device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- signed written consent
- symptomatic patients (NYHA-stadium ≥ III) for at least 3 months with an exploited medical heart insufficiency therapy
- increased perioperative risk with a logistic EuroScore ≥ 15 or STS-Score ≥ 15
- MR grade ≥ 2, amenable for MitraClip intervention assessed by an experienced interventional cardiologist
Key exclusion criteria (3 listed)
- one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation
- implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months
- solid tumor with a live expectancy < 1 year
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 |
|---|---|---|
| percutaneous treatment by implanting a Mitra Clip deviceAlso: Mitra Clip systemWith a minimal-invasive, percutaneous catheter-based technique and trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance, the MitraClip device grasps and approximates the mitral leaflets thus creating a double-orifice mitral valve with a permanent leaflet coaptation and a reduction or even abrogation of mitral regurgitation. | Device | optimal medical treatment, percutaneous treatment |
Primary outcome
Improvement of Dyspnoea of at least one class (NYHA-Classification)
Time frame: after 6 months
1 secondary outcome
composite endpoint and clinical outcome measured by NYHA-classification
Time frame: 1 year and 2 years after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
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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.
Joerg Hausleiter, MD study chair
Deutsches Herzzentrum Muenchen
Steffen Massberg, MD principal investigator
Deutsches Herzzentrum Muenchen
Juergen Pache, MD principal investigator
Deutsches Herzzentrum Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing percutaneous treatment by implanting a Mitra Clip device in people with Mitral Regurgitation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Sep 2011. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joerg Hausleiter, MD (+49-89-1218-0 ext. 4018, hausleiter@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Dyspnoea of at least one class (NYHA-Classification) (time frame: after 6 months). 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 2011.