Aortic Valve StenosisNCT05662748
Comparison Between Manta and Prostar Closure Devices
An observational study of Aortic Valve Stenosis, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Use of the closure device in patient with percutaneous transfemoral 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?
- Transfemoral aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2020to 30 Mar 2021
- How long will I take part?
- 14 Days
- 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: Patient with planned treatment of aortic valve replacement will be asked to participate in the observational study
Who may be able to join
- Patient scheduled for treatment with the TAVR device 2. Decision to use the Manta or the Prostar closure device on a clinical base by the treating physician 3. Signed informed consent
Who cannot join
- Male or female aged < 18 2. Pregnant and lactating females 3. Patient has been committed to an institution by legal or regulatory order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Use of the Closure Device in Patient With Percutaneous Transfemoral Aortic Valve Replacement
Use of the closure device in patient with percutaneous transfemoral aortic valve replacement
Read the detailed description
The advent of endovascular, transcatheter aortic valve replacement (TAVR), and mechanical circulatory support has offered new, minimally invasive therapeutic options that are rapidly becoming standard of care. These percutaneous transfemoral interventions require large-bore catheters and have created challenges for femoral arterial access management. Current approaches include surgical cut-down with arterial puncture under direct vision, and suture-based "pre-closure." Surgical cut-down is associated with longer procedural time, increased patient discomfort, deeper anesthesia, risk of wound complications including infection, and slower ambulation. The pre-closure technique overcomes many of the disadvantages of surgical cut-down but can be technically demanding, time consuming, and associated with a significant failure rate. Recent randomized TAVR trials have reported major vascular complications in 6% to 8% . Furthermore, a study on the 2 suture-based closure techniques for management of TAVR access reported a 20% vascular complication rate despite being used by experienced operators . Currently, the majority of access site complications result from failed arteriotomy closure . The percutaneous MANTA Vascular Closure Device (VCD) (Essential Medical Inc., Malvern, Pennsylvania) is a novel collagen-based technology dedicated to closure of largebore arteriotomies . The MANTA VCD underwent prospective multicenter evaluation for Conformitä Europäenne (CE) mark approval in the first detailed report of outcomes achieved with a dedicated large-bore vascular closure device Contrary to the aforementioned TAVR procedures, mechanical circulatory support therapy can be extended up to several days on the intensive care ward. Data on such delayed closure with is lacking. This registry is therefore aimed to document the initial experiences of delayed closure of a femoral large bore access with vascular closure devices in patients with an TAVR device.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transfemoral aortic valve replacement
- Keywords
- Closure
- 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.
Transfemoral aortic valve replacementDevice
aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Pro Star | patient received Pro Star Device Receives: Device: Transfemoral aortic valve replacement | |
| MANTA | Patient received MANTA Device Receives: Device: Transfemoral aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints during index hospitalisation
Major vascular complications,
Measured: 2018 - 2020
Safety endpoints during index hospitalisation ( bleeding)
life-threatining-, major bleeding
Measured: 2018-2020
Safety endpoints during index hospitalisation ( death )
death
Measured: 2018-2020
Secondary outcomes (3)
efficacy endpoints during index hospitalisation - (hemotasis)
hemotasis in angiogram
Measured: 2018-2020
efficacy endpoints during index hospitalisation ( device failure)
device failure
Measured: 2018-2020
efficacy endpoints during index hospitalisation ( bail-out )
need for stent-graft
Measured: 2018-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start20 Jan 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jörg Schröder, RWTH Aachen University
- Investigators
- Jörg Schröder, Principal investigator, Universitätsklinikum Aachen Medizinische Klinik 1Michael Lehrke, Principal investigator, Universitätsklinikum Aachen Medizinische Klinik 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662748
- Sponsor's protocol ID
- RWTH AachenU
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be published in an appropriate scientific journal. The Ethics Committee will be informed about the study results.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Closure Device in Patient With Percutaneous Transfemoral Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT05662748
- Acronym / sponsor ID
- RWTH AachenU
- Conditions
- Aortic Valve Stenosis
- Keywords
- Closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 22 Dec 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.
Use of the closure device in patient with percutaneous transfemoral aortic valve replacement
Detailed description
The advent of endovascular, transcatheter aortic valve replacement (TAVR), and mechanical circulatory support has offered new, minimally invasive therapeutic options that are rapidly becoming standard of care. These percutaneous transfemoral interventions require large-bore catheters and have created challenges for femoral arterial access management. Current approaches include surgical cut-down with arterial puncture under direct vision, and suture-based "pre-closure." Surgical cut-down is associated with longer procedural time, increased patient discomfort, deeper anesthesia, risk of wound complications including infection, and slower ambulation. The pre-closure technique overcomes many of the disadvantages of surgical cut-down but can be technically demanding, time consuming, and associated with a significant failure rate. Recent randomized TAVR trials have reported major vascular complications in 6% to 8% . Furthermore, a study on the 2 suture-based closure techniques for management of TAVR access reported a 20% vascular complication rate despite being used by experienced operators . Currently, the majority of access site complications result from failed arteriotomy closure . The percutaneous MANTA Vascular Closure Device (VCD) (Essential Medical Inc., Malvern, Pennsylvania) is a novel collagen-based technology dedicated to closure of largebore arteriotomies . The MANTA VCD underwent prospective multicenter evaluation for Conformitä Europäenne (CE) mark approval in the first detailed report of outcomes achieved with a dedicated large-bore vascular closure device Contrary to the aforementioned TAVR procedures, mechanical circulatory support therapy can be extended up to several days on the intensive care ward. Data on such delayed closure with is lacking. This registry is therefore aimed to document the initial experiences of delayed closure of a femoral large bore access with vascular closure devices in patients with an TAVR device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pro Star | – | Device: Transfemoral aortic valve replacementpatient received Pro Star Device |
| MANTA | – | Device: Transfemoral aortic valve replacementPatient received MANTA Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with planned treatment of aortic valve replacement will be asked to participate in the observational study
Key inclusion criteria (1 listed)
- Patient scheduled for treatment with the TAVR device 2. Decision to use the Manta or the Prostar closure device on a clinical base by the treating physician 3. Signed informed consent
Key exclusion criteria (1 listed)
- Male or female aged < 18 2. Pregnant and lactating females 3. Patient has been committed to an institution by legal or regulatory order
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 |
|---|---|---|
| Transfemoral aortic valve replacementaortic valve replacement | Device | MANTA, Pro Star |
Primary outcome
Safety endpoints during index hospitalisation
Time frame: 2018 - 2020
Major vascular complications,
Safety endpoints during index hospitalisation ( bleeding)
Time frame: 2018-2020
life-threatining-, major bleeding
Safety endpoints during index hospitalisation ( death )
Time frame: 2018-2020
death
3 secondary outcomes
efficacy endpoints during index hospitalisation - (hemotasis)
Time frame: 2018-2020
efficacy endpoints during index hospitalisation ( device failure)
Time frame: 2018-2020
efficacy endpoints during index hospitalisation ( bail-out )
Time frame: 2018-2020
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 22 Dec 2022.
- Individual participant dataSharing planned: No. Study results will be published in an appropriate scientific journal. The Ethics Committee will be informed about the study results.
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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.
Jörg Schröder principal investigator
Universitätsklinikum Aachen Medizinische Klinik 1
Michael Lehrke principal investigator
Universitätsklinikum Aachen Medizinische Klinik 1
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 RWTH Aachen University at 1 site in Germany.
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 22 Dec 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 Germany. 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?
Safety endpoints during index hospitalisation (time frame: 2018 - 2020). The study lists 3 primary outcomes in all. 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 22 Dec 2022.