Aortic Valve StenosisMASH-TAVINCT03811119
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
A study testing MANTA vascular closure device and Suture based vascular closure device in people with Aortic Valve Stenosis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- MANTA vascular closure device and Suture based vascular closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Oct 2018to 30 Apr 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV)
- Common femoral artery diameter > 5.0mm (14 - 22F compatible)
Who cannot join
- Symptomatic leg ischaemia
- Previous thromboendarterectomy or plastic patch of the common femoral artery
- Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months
- Unilateral or bilateral lower extremity amputation
- Systemic infection or a local infection at or near the access site
- Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel)
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- Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure
- Patient unable to be adequately anti-coagulated for the procedure
- Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
- Anatomical and procedural contraindication for suture-based or Manta closure (lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease)
- Absence of computed tomographic data of the access site before the procedure
- Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
- Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory)
- Participating in trials in which the primary endpoint includes bleeding or vascular complications
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Medical Center Rotterdam
Rotterdam, 3000 CA
About this study
Official title: MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.
Read the detailed description
see summary
- Conditions
- Aortic Valve Stenosis
- Being tested
- MANTA vascular closure device, Suture based vascular closure device
- Keywords
- Vascular Closure Devices, Transcatheter Aortic Valve Implantation
- 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
Collagen based vascular closure device
Suture based vascular closure deviceDevice
Suture based vascular closure device (ProGlide)
| Study group | Role | What they receive |
|---|---|---|
| MANTA vascular closure device | Active comparator | Arteriotomy closure with a collagen-based vascular closure device (MANTA™) Receives: Device: MANTA vascular closure device |
| Suture based vascular closure device | Active comparator | Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide) Receives: Device: Suture based vascular closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of major- and minor vascular complications according to VARC-2
The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
Secondary outcomes (10)
Number of Participants with a Major Vascular Complication according to VARC-2
total number of participants major vascular complications
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with a Minor Vascular Complication according to VARC-2
total number of participants minor vascular complications
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
All-cause death rate
A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with a major- or life threatening bleeding according to VARC-2
total number of participants with major/life-threatening bleedings
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
Need for transfusions for access site related bleeding/complications
Total number of transfusions of RBC because of site-related bleeding
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with vascular closure device failure
Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
Time to hemostasis
After the use of a vascular closure device the time to hemostasis will be classified as immediate hemostasis, hemostasis after 5 minutes manual compression, hemostasis after 10 minutes manual compression, hemostasis after endovascular ballooning, hemostasis after endovascular intervention or hemostasis after surgical intervention
Measured: During the TAVI procedure
Total procedure time
The total procedural time in minutes will be compared between the two treatment arms
Measured: During the TAVI procedure
Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5
Clinically relevant bleeding defined as BARC 2, 3 and 5
Measured: Between transcatheter aortic valve implantation and 30 days follow-up
Length of hospital stay
The total length of hospital stay in days will be compared between the two treatment arms
Measured: Up to a maximum of 30 days after the TAVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start30 Oct 2018
- Primary completion1 Feb 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized trial
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas M Van Mieghem, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811119
- Sponsor's protocol ID
- MASH TAVI 06-09-2018
- Acronym
- MASH-TAVI
- Status last verified
- Mar 2021
- First submitted
- 17 Jan 2019
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing of individual data (no permission from participants. GDPR)
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
- ClinicalTrials.gov ID
- NCT03811119
- Acronym / sponsor ID
- MASH-TAVI / MASH TAVI 06-09-2018
- Conditions
- Aortic Valve Stenosis
- Keywords
- Vascular Closure Devices, Transcatheter Aortic Valve Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 22 Jan 2019 (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.
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.
Detailed description
see summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized trial
| Arm | Type | Receives |
|---|---|---|
| MANTA vascular closure device | Active comparator | Device: MANTA vascular closure deviceArteriotomy closure with a collagen-based vascular closure device (MANTA™) |
| Suture based vascular closure device | Active comparator | Device: Suture based vascular closure deviceArteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV)
- Common femoral artery diameter > 5.0mm (14 - 22F compatible)
Key exclusion criteria (15 listed)
- Symptomatic leg ischaemia
- Previous thromboendarterectomy or plastic patch of the common femoral artery
- Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months
- Unilateral or bilateral lower extremity amputation
- Systemic infection or a local infection at or near the access site
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 deviceCollagen based vascular closure device | Device | MANTA vascular closure device |
| Suture based vascular closure deviceSuture based vascular closure device (ProGlide) | Device | Suture based vascular closure device |
Primary outcome
Composite rate of major- and minor vascular complications according to VARC-2
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.
10 secondary outcomes
Number of Participants with a Major Vascular Complication according to VARC-2
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with a Minor Vascular Complication according to VARC-2
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
All-cause death rate
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with a major- or life threatening bleeding according to VARC-2
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Need for transfusions for access site related bleeding/complications
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with vascular closure device failure
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Time to hemostasis
Time frame: During the TAVI procedure
Total procedure time
Time frame: During the TAVI procedure
Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Length of hospital stay
Time frame: Up to a maximum of 30 days after the TAVI procedure
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 29 Mar 2021.
- Individual participant dataSharing planned: No. no sharing of individual data (no permission from participants. GDPR)
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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.
Nicolas M Van Mieghem, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MANTA vascular closure device and Suture based vascular closure device in people with Aortic Valve Stenosis, run by Erasmus Medical Center at 1 site in Netherlands.
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 15 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 29 Mar 2021. 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 Netherlands. 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?
Composite rate of major- and minor vascular complications according to VARC-2 (time frame: Between transcatheter aortic valve implantation and 30 days follow-up). 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 29 Mar 2021.