Mitral RegurgitationNCT05865938
PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair
An observational study of Mitral Regurgitation and Functional Mitral Regurgitation, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- What is being tested?
- PASCAL vs. MitraClip
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 31 Aug 2022
- Phase
- Observational
- 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
Study population: Patients with severe symptomatic mitral regurgitation.
Who may be able to join
- Age ≥18 years
- Severe Mitral Regurgitation (3+ to 4+)
- Symptom status: NYHA functional class ≥ II
- Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high
Who cannot join
- Life expectancy < 1 year
- Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
- Contraindication for transoesophageal echocardiography
- Active endocarditis
- Pregnant or planning pregnancy within next 12 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study
Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.
Read the detailed description
A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection.
Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols.
This study is a subproject of the MitraClip® Registry (NCT02033811)
- Conditions
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- Being tested
- PASCAL vs. MitraClip
- Keywords
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation, M-TEER, TEER
- 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.
PASCAL vs. MitraClipDevice
transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR).
The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.
| Study group | Role | What they receive |
|---|---|---|
| PASCAL-Group | M-TEER using MitraClip Receives: Device: PASCAL vs. MitraClip | |
| MitraClip-Group | M-TEER using PASCAL Receives: Device: PASCAL vs. MitraClip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
as defined by the Mitral Valve Academy Research Consortium (MVARC)
Measured: one month after implantation
Composite endpoint of all-cause death and heart failure hospitalization
Measured: one year after implantation
Secondary outcomes (2)
Grade of Mitral Regurgitation
measured by echocardiography
Measured: one month and one year after implantation
Functional status
according to New York Heart Association (NYHA) functional class
Measured: one month and one year after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jun 2019
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Clinic for Cardiology, Pneumology and Angiology at University Hospital DüsseldorfPatrick Horn, MD, Principal investigator, Clinic for Cardiology, Pneumology and Angiology at University Hospital DüsseldorfJafer Haschemi, MD, Principal investigator, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865938
- Sponsor's protocol ID
- PASCAL vs. MitralClip
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study
- ClinicalTrials.gov ID
- NCT05865938
- Acronym / sponsor ID
- PASCAL vs. MitralClip
- Conditions
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- Keywords
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation, M-TEER, TEER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 May 2023 (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.
Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.
Detailed description
A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection.
Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols.
This study is a subproject of the MitraClip® Registry (NCT02033811)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASCAL-Group | – | Device: PASCAL vs. MitraClipM-TEER using MitraClip |
| MitraClip-Group | – | Device: PASCAL vs. MitraClipM-TEER using PASCAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe symptomatic mitral regurgitation.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Severe Mitral Regurgitation (3+ to 4+)
- Symptom status: NYHA functional class ≥ II
- Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high
Key exclusion criteria (5 listed)
- Life expectancy < 1 year
- Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
- Contraindication for transoesophageal echocardiography
- Active endocarditis
- Pregnant or planning pregnancy within next 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 |
|---|---|---|
| PASCAL vs. MitraCliptranscatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. | Device | MitraClip-Group, PASCAL-Group |
Primary outcome
Procedural success
Time frame: one month after implantation
as defined by the Mitral Valve Academy Research Consortium (MVARC)
Composite endpoint of all-cause death and heart failure hospitalization
Time frame: one year after implantation
2 secondary outcomes
Grade of Mitral Regurgitation
Time frame: one month and one year after implantation
Functional status
Time frame: one month and one year after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- 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.
Malte Kelm, Prof. study chair
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Patrick Horn, MD principal investigator
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Jafer Haschemi, MD principal investigator
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Functional Mitral Regurgitation, run by Heinrich-Heine University, Duesseldorf 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 4 inclusion and 5 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 19 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Procedural success (time frame: one month after implantation). 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 19 May 2023.