Mitral Valve DiseaseNCT03697941
Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery
An observational study of Mitral Valve Disease, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Percutaneous arteriotomy closed using a plug-based arteriotomy closure device and Surgical cut-down and arterial puncture under direct vision
- Type of treatment
- Surgery or procedure
- How many people
- 268 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2016to Jun 2019
- 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: Patientes operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.
Who may be able to join
- Operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review and from the Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) electronic data collection platform.
- Conditions
- Mitral Valve Disease
- Being tested
- Percutaneous arteriotomy closed using a plug-based arteriotomy closure device, Surgical cut-down and arterial puncture under direct vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous arteriotomy closed using a plug-based arteriotomy closure deviceProcedure or surgery
Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).
Surgical cut-down and arterial puncture under direct visionProcedure or surgery
Surgical cut-down and arterial puncture under direct vision.
| Study group | Role | What they receive |
|---|---|---|
| Surgical cut-down and arterial puncture under direct vision | Not described Receives: Procedure: Surgical cut-down and arterial puncture under direct vision | |
| Percutaneous arteriotomy closed with closure device | Not described Receives: Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major vascular groin-related complication according to the VARC-2 definition criteria
Measured: During the first 8 weeks after surgery
Secondary outcomes (3)
Minor vascular groin-related complication according to the VARC-2 definition criteria
Measured: During the first 8 weeks after surgery
Access-site related groin seroma
Measured: During the first 8 weeks after surgery
Access-site related groin infection
Measured: During the first 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study startFeb 2016
- Primary completionMar 2019
- Study completionJun 2019
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 Valve DiseaseStudies 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
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Dalén, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697941
- Sponsor's protocol ID
- MIMVS-MANTA
- Status last verified
- Aug 2019
- First submitted
- 4 Oct 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data not planned to be shared.
Publications
Kastengren M, Svenarud P, Kallner G, Settergren M, Franco-Cereceda A, Dalen M. Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery. Ann Thorac Surg. 2020 Jul;110(1):85-91. doi: 10.1016/j.athoracsur.2019.10.038. Epub 2019 Nov 30.
PubMed 31794742
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT03697941
- Acronym / sponsor ID
- MIMVS-MANTA
- Conditions
- Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 5 Oct 2018 (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.
A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review and from the Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) electronic data collection platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical cut-down and arterial puncture under direct vision | – | Procedure: Surgical cut-down and arterial puncture under direct vision |
| Percutaneous arteriotomy closed with closure device | – | Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patientes operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.
Key inclusion criteria (1 listed)
- Operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.
Key exclusion criteria (1 listed)
- None.
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 arteriotomy closed using a plug-based arteriotomy closure devicePercutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). | Procedure or surgery | Percutaneous arteriotomy closed with closure device |
| Surgical cut-down and arterial puncture under direct visionSurgical cut-down and arterial puncture under direct vision. | Procedure or surgery | Surgical cut-down and arterial puncture under direct vision |
Primary outcome
Major vascular groin-related complication according to the VARC-2 definition criteria
Time frame: During the first 8 weeks after surgery
3 secondary outcomes
Minor vascular groin-related complication according to the VARC-2 definition criteria
Time frame: During the first 8 weeks after surgery
Access-site related groin seroma
Time frame: During the first 8 weeks after surgery
Access-site related groin infection
Time frame: During the first 8 weeks after surgery
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 13 Aug 2019.
- Derived from this study: PubMed 31794742Kastengren M, Svenarud P, Kallner G, Settergren M, Franco-Cereceda A, Dalen M. Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery. Ann Thorac Surg. 2020 Jul;110(1):85-91. doi: 10.1016/j.athoracsur.2019.10.038. Epub 2019 Nov 30.
- Individual participant dataSharing planned: No. Individual participant data not planned to be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Valve Disease, run by Karolinska University Hospital at 1 site in Sweden.
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 1 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 13 Aug 2019. 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 Sweden. 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?
Major vascular groin-related complication according to the VARC-2 definition criteria (time frame: During the first 8 weeks after surgery). 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 NCT03697941, 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 13 Aug 2019; AzTrials last refreshed its copy on 31 Oct 2026.