Aortic Valve StenosisNCT04392492
Vascular Closure Device in Transcatheter Aortic Valve Replacement
An observational study of Aortic Valve Stenosis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- MANTA vascular closure device
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jan 2017to 31 Jan 2021
- How long will I take part?
- 6 Weeks
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients undergoing TAVI at the Karolinska University Hospital
Who may be able to join
- Patients undergoing transfemoral TAVI at the Karolinska University Hospital
Who cannot join
- Patients undergoing TAVI with access other than transfemoral
- Use of closure device other than MANTA
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiology, Karolinska University Hospital
Stockholm
About this study
Official title: Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.
- Conditions
- Aortic Valve Stenosis
- Being tested
- MANTA vascular closure device
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANTA vascular closure deviceDevice
Femoral access site closure using the MANTA closure device
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing transfemoral TAVI with MANTA closure | Patients undergoing transfemoral transcatheter aortic valve replacement with femoral access site closure using the novel plug-based vascular closure device (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA). Receives: Device: MANTA vascular closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major vascular complications
Major vascular access site complications according to the VARC-2 definitions
Measured: 6 week follow up
Secondary outcomes (3)
Number of patients with minor vascular complications
Minor vascular access site complications according to the VARC-2 definitions
Measured: 6 week follow up
Number of patients with vascular closure device failure
Percutaneous vascular closure device failure according to the VARC-2 definitions
Measured: 6 week follow up
Number of patients with life-threatening, disabling or major bleeding
Life-threatening, disabling or major bleeding complications according to the BARC definitions
Measured: 6 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start25 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (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 Aortic Valve StenosisStudies 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
- 1,000 participants (estimated)
- Target duration
- 6 Weeks
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
- NCT04392492
- Sponsor's protocol ID
- MANTA TAVI
- Status last verified
- Nov 2020
- First submitted
- 13 May 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kastengren M, Settergren M, Ruck A, Feldt K, Saleh N, Linder R, Verouhis D, Meduri CU, Bager J, Dalen M. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022 Jul 15;359:7-13. doi: 10.1016/j.ijcard.2022.04.033. Epub 2022 Apr 12.
PubMed 35427700
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04392492
- Acronym / sponsor ID
- MANTA TAVI
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 18 May 2020 (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.
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing transfemoral TAVI with MANTA closure | – | Device: MANTA vascular closure devicePatients undergoing transfemoral transcatheter aortic valve replacement with femoral access site closure using the novel plug-based vascular closure device (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients undergoing TAVI at the Karolinska University Hospital
Key inclusion criteria (1 listed)
- Patients undergoing transfemoral TAVI at the Karolinska University Hospital
Key exclusion criteria (2 listed)
- Patients undergoing TAVI with access other than transfemoral
- Use of closure device other than MANTA
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 |
|---|---|---|
| MANTA vascular closure deviceFemoral access site closure using the MANTA closure device | Device | Patients undergoing transfemoral TAVI with MANTA closure |
Primary outcome
Number of patients with major vascular complications
Time frame: 6 week follow up
Major vascular access site complications according to the VARC-2 definitions
3 secondary outcomes
Number of patients with minor vascular complications
Time frame: 6 week follow up
Number of patients with vascular closure device failure
Time frame: 6 week follow up
Number of patients with life-threatening, disabling or major bleeding
Time frame: 6 week follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Derived from this study: PubMed 35427700Kastengren M, Settergren M, Ruck A, Feldt K, Saleh N, Linder R, Verouhis D, Meduri CU, Bager J, Dalen M. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022 Jul 15;359:7-13. doi: 10.1016/j.ijcard.2022.04.033. Epub 2022 Apr 12.
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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 Aortic Valve Stenosis, 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 2 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 2 Dec 2020. 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?
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 major vascular complications (time frame: 6 week follow up). 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 NCT04392492, 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 2 Dec 2020.