Mitral RegurgitationNCT02023762
Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
An observational study of Mitral Regurgitation and Local Anaesthesia, run by Heinrich-Heine University, Duesseldorf.
Trial summary
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia, but the MitraClip® is also feasible in deep sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Local Anaesthesia, Percutaneous Repair
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2013
- 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 mitral regurgitation characterized by trans-thoracic and trans-esophageal echocardiography undergoing PMVR using the MitraClip® system
Who may be able to join
- severe mitral regurgitation
- PMVR using the MitraClip® system
Who cannot join
- -
About this study
Official title: Safety and Feasibility of Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia, but the MitraClip® is also feasible in deep sedation.
The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
Read the detailed description
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery.
The PMVR procedure, however, is typically performed under general anaesthesia. It has recently been shown in a first approach that performing the MitraClip® in deep sedation is feasible; however safety parameters and a direct comparison to general anaesthesia are still missing The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
- Conditions
- Mitral Regurgitation, Local Anaesthesia, Percutaneous Repair
- Keywords
- mitral regurgitation, local anaesthesia, percutaneous repair
- Medical subject headings
- Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse Events
Evaluation of feasibility and safety of deep sedation instead of general anaesthesia
Measured: patients will be followed for the duration of procedure until discharge, an expected average of 10 days
Secondary outcomes (5)
preparation and procedure time
Measured: procedure
Overall time to discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Changes in 6-Minute Walk Test
Measured: Baseline to 1 month after intervention
Changes in NYHA class
Measured: Baseline to 1 month after intervention
Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Measured: Baseline to 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Tienush Rassaf, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital DusseldorfMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023762
- Sponsor's protocol ID
- MitraClip under sedation
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rassaf T, Balzer J, Zeus T, Rammos C, Shayganfar S, Hall SV, Wagstaff R, Kelm M. Safety and efficacy of deep sedation as compared to general anaesthesia in percutaneous mitral valve repair using the MitraClip system. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):E38-42. doi: 10.1002/ccd.25570. Epub 2014 Jul 4.
PubMed 24909413
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
- ClinicalTrials.gov ID
- NCT02023762
- Acronym / sponsor ID
- MitraClip under sedation
- Conditions
- Mitral Regurgitation, Local Anaesthesia, Percutaneous Repair
- Keywords
- mitral regurgitation, local anaesthesia, percutaneous repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Dec 2013 (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.
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia, but the MitraClip® is also feasible in deep sedation.
The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
Detailed description
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery.
The PMVR procedure, however, is typically performed under general anaesthesia. It has recently been shown in a first approach that performing the MitraClip® in deep sedation is feasible; however safety parameters and a direct comparison to general anaesthesia are still missing The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe mitral regurgitation characterized by trans-thoracic and trans-esophageal echocardiography undergoing PMVR using the MitraClip® system
Key inclusion criteria (2 listed)
- severe mitral regurgitation
- PMVR using the MitraClip® system
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with adverse Events
Time frame: patients will be followed for the duration of procedure until discharge, an expected average of 10 days
Evaluation of feasibility and safety of deep sedation instead of general anaesthesia
5 secondary outcomes
preparation and procedure time
Time frame: procedure
Overall time to discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Changes in 6-Minute Walk Test
Time frame: Baseline to 1 month after intervention
Changes in NYHA class
Time frame: Baseline to 1 month after intervention
Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Time frame: Baseline to 1 month after intervention
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 30 Dec 2013.
- Derived from this study: PubMed 24909413Rassaf T, Balzer J, Zeus T, Rammos C, Shayganfar S, Hall SV, Wagstaff R, Kelm M. Safety and efficacy of deep sedation as compared to general anaesthesia in percutaneous mitral valve repair using the MitraClip system. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):E38-42. doi: 10.1002/ccd.25570. Epub 2014 Jul 4.
- Related InfoLink provided by the sponsor.
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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.
Tienush Rassaf, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Local Anaesthesia, run by Heinrich-Heine University, Duesseldorf.
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 2 inclusion and 1 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 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with adverse Events (time frame: patients will be followed for the duration of procedure until discharge, an expected average of 10 days). 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 NCT02023762, which also lists 1 linked publication.
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 30 Dec 2013.