Mitral RegurgitationLEAFLET INCT06634121
Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
A study testing Transcatheter mitral valve edge-to-edge repair (M-TEER) in people with Mitral Regurgitation and Valvular Heart Disease, run by LMU Klinikum at 1 site in Germany.
Trial summary
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Valvular Heart Disease, Heart Failure
- What is being tested?
- Transcatheter mitral valve edge-to-edge repair (M-TEER)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2024to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 equal or above 18 years
- Written consent
- Heart Team recommends M-TEER
Who cannot join
- Mitral Stenosis (MV mean PG > 5 mmHg)
- Cardiogenic shock or hemodynamic instability at the time of intervention
- Active endocarditis
- Participant in another interventional cardiology study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ludwig Weckbach, PD Dr. contact
Germany1 site, 1 recruiting
- Recruiting
LMU Klinikum
Munich, Bavaria, 81377
Jörg Hausleiter, Prof. Dr., +4989440072361, Joerg.Hausleiter@med.uni-muenchen.de
Ludwig Weckbach, PD Dr., Ludwig.Weckbach@med.uni-muenchen.de
About this study
Official title: Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.
Read the detailed description
In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.
- Conditions
- Mitral Regurgitation, Valvular Heart Disease, Heart Failure
- Being tested
- Transcatheter mitral valve edge-to-edge repair (M-TEER)
- Keywords
- Mitral Regurgitation, TEER, MitraClip, PASCAL
- Medical subject headings
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter mitral valve edge-to-edge repair (M-TEER)Device
M-TEER is performed via a transfemoral venous approach. After puncture of the interatrial septum the mitral valve is repaired using either the PASCAL or MitraClip device.
| Study group | Role | What they receive |
|---|---|---|
| MitraClip | Active comparator | Not described Receives: Device: Transcatheter mitral valve edge-to-edge repair (M-TEER) |
| PASCAL | Active comparator | Not described Receives: Device: Transcatheter mitral valve edge-to-edge repair (M-TEER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprocedural residual MR measured by 3D EROA
residual MR measured by 3D EROA as continuous parameter
Measured: During the index procedure
Secondary outcomes (10)
Reduction in MR EROA
Reduction in MR EROA from baseline to postprocedural (relative and absolut value)
Measured: During the index procedure
Comparing EROA in complex vs. non-complex patients
Evaluation according to EROA reduction
Measured: During the index procedure
Postprocedural MV opening area
Postprocedural MV opening area (planimetric)
Measured: During the index procedure
Postprocedural MV inflow gradient
Mean pressure gradient and pressure halftime
Measured: During the index procedure
SLDA
Single Leaflet Device Attachment
Measured: During the index procedure, at 30-day follow-up and at 1-year follow-up
Conversion to surgery or re-imaging of the MV
Conversion to surgery (urgently or elective) or re-imaging of the MV
Measured: During the index procedure, at 30-day follow-up and at 1-year follow-up
Stratification by MR etiology
Primary vs. Secondary MR
Measured: During the index procedure, at 30-day follow-up and at 1-year follow-up
Combined endpoint of mortality, repeat MV intervention or HHF
Assessed at 30-days and 1-year
Measured: During the index procedure, at 30-day follow-up and at 1-year follow-up
Quality of Life
Measured using the KCCQ Score
Measured: At 30-day follow-up and at 1-year follow-up
Exertional dyspnea
NYHA functional class
Measured: At 30-day follow-up and at 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Jörg Hausleiter, LMU Klinikum
- Investigators
- Jörg Hausleiter, Prof. Dr., Principal investigator, LMU KlinikumLudwig Weckbach, PD Dr., Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634121
- Sponsor's protocol ID
- LEAFLET I
- Acronym
- LEAFLET I
- Status last verified
- Oct 2024
- First submitted
- 26 Aug 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
- ClinicalTrials.gov ID
- NCT06634121
- Acronym / sponsor ID
- LEAFLET I / LEAFLET I
- Conditions
- Mitral Regurgitation, Valvular Heart Disease, Heart Failure
- Keywords
- Mitral Regurgitation, TEER, MitraClip, PASCAL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 9 Oct 2024 (actual)
- 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.
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.
Detailed description
In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitraClip | Active comparator | Device: Transcatheter mitral valve edge-to-edge repair (M-TEER) |
| PASCAL | Active comparator | Device: Transcatheter mitral valve edge-to-edge repair (M-TEER) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal or above 18 years
- Written consent
- Heart Team recommends M-TEER
Key exclusion criteria (4 listed)
- Mitral Stenosis (MV mean PG > 5 mmHg)
- Cardiogenic shock or hemodynamic instability at the time of intervention
- Active endocarditis
- Participant in another interventional cardiology study
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 |
|---|---|---|
| Transcatheter mitral valve edge-to-edge repair (M-TEER)M-TEER is performed via a transfemoral venous approach. After puncture of the interatrial septum the mitral valve is repaired using either the PASCAL or MitraClip device. | Device | MitraClip, PASCAL |
Primary outcome
Postprocedural residual MR measured by 3D EROA
Time frame: During the index procedure
residual MR measured by 3D EROA as continuous parameter
10 secondary outcomes
Reduction in MR EROA
Time frame: During the index procedure
Comparing EROA in complex vs. non-complex patients
Time frame: During the index procedure
Postprocedural MV opening area
Time frame: During the index procedure
Postprocedural MV inflow gradient
Time frame: During the index procedure
SLDA
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
Conversion to surgery or re-imaging of the MV
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
Stratification by MR etiology
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
Combined endpoint of mortality, repeat MV intervention or HHF
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
Quality of Life
Time frame: At 30-day follow-up and at 1-year follow-up
Exertional dyspnea
Time frame: At 30-day follow-up and at 1-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ludwig Weckbach, PD Dr. contact
Jörg Hausleiter, Prof. Dr. principal investigator
LMU Klinikum
Ludwig Weckbach, PD Dr. principal investigator
LMU Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter mitral valve edge-to-edge repair (M-TEER) in people with Mitral Regurgitation and Valvular Heart Disease, run by LMU Klinikum 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jörg Hausleiter, Prof. Dr. (+4989440072361, Joerg.Hausleiter@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprocedural residual MR measured by 3D EROA (time frame: During the index procedure). 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 Oct 2024.