Minimally Invasive Cardiac SurgeryNCT05462769
Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Cardiac Surgery
An observational study of Minimally Invasive Cardiac Surgery, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
A single-center prospective study. Patients undergoing minimally invasive cardiac surgery between 2017 and 2022 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
- Minimally Invasive Cardiac Surgery
- What is being tested?
- Percutaneous vascular closure
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2017to Dec 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
- Adult, Older adult
Study population: Patients operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.
Who may be able to join
- Operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation 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.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Magnus Dalén, MD, PhD
About this study
A single-center prospective study. Patients undergoing minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA; Teleflex/Essential Medical, Malvern, PA). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.
- Conditions
- Minimally Invasive Cardiac Surgery
- Being tested
- Percutaneous vascular closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous vascular closureDevice
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.
Any vascular groin-related complication
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 posted18 Jul 2022
- Study start1 Aug 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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 Minimally Invasive Cardiac SurgeryStudies 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
- 600 participants (estimated)
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
- NCT05462769
- Sponsor's protocol ID
- MANTA continued
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma K, Kastengren M, Svenarud P, Green R, Dalen M. Routine use of percutaneous femoral cannulation in minimally invasive cardiac surgery. Eur J Cardiothorac Surg. 2023 Mar 1;63(3):ezad020. doi: 10.1093/ejcts/ezad020.
PubMed 36692172
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. 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 Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05462769
- Acronym / sponsor ID
- MANTA continued
- Conditions
- Minimally Invasive Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Jul 2022 (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 cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA; Teleflex/Essential Medical, Malvern, PA). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.
Key inclusion criteria (1 listed)
- Operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation 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 vascular closurePercutaneous arteriotomy closed using a plug-based arteriotomy closure device | Device | – |
Primary outcome
Any vascular groin-related complication
Time frame: During the first 8 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 36692172Ma K, Kastengren M, Svenarud P, Green R, Dalen M. Routine use of percutaneous femoral cannulation in minimally invasive cardiac surgery. Eur J Cardiothorac Surg. 2023 Mar 1;63(3):ezad020. doi: 10.1093/ejcts/ezad020.
- 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.
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 Minimally Invasive Cardiac Surgery, 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: status not confirmed, as of the sponsor's last update on 18 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magnus Dalén (+46 (0) 8 123 700 00, magnus.dalen@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any vascular groin-related complication (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 NCT05462769, 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 18 Jul 2022.