Aortic Valve StenosisCHOICE-CLOSURENCT04459208
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
A study testing Manta and ProGlide in people with Aortic Valve Stenosis, run by Helios Health Institute GmbH at 1 site in Germany.
Trial summary
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). 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 and ProGlide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jun 2020to 4 Aug 2021
- 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 with an indication for transfemoral TAVI as judged by the local heart team.
- Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
- The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.
Who cannot join
- Vascular access site anatomy not suitable for percutaneous vascular closure.
- Vascular access site complications prior to the TAVI procedure.
- Known allergy or hypersensitivity to any VCD component.
- Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
- Absence of computed tomographic data of the access site before the procedure.
- Systemic infection or a local infection at or near the access site.
Show all 10Show fewer
- Life expectancy of less than 6 months due to non-cardiac conditions.
- Patient cannot adhere to or complete the investigational protocol for any reason.
- Pregnant or nursing subjects.
- Participation in any other interventional trial.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.
Read the detailed description
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Manta, ProGlide
- Keywords
- Vascular access site closure, Transcatheter aortic valve implantation, Vascular closure device, Vascular access-site injury
- 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.
MantaDevice
plug-based vascular closure
ProGlideDevice
suture-based vascular closure
| Study group | Role | What they receive |
|---|---|---|
| Manta | Active comparator | plug-based vascular closure Receives: Device: Manta |
| ProGlide | Active comparator | suture-based vascular closure Receives: Device: ProGlide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Measured: up to 7 days
Secondary outcomes (18)
Rate of access-site or access-related vascular injury
Rate of access-site or access-related vascular injury
Measured: 30 days
Rate of major access-site or access-related vascular injury
Rate of major access-site or access-related vascular injury
Measured: up to 7 days and at 30 days
Rate of minor access site or access-related vascular injury
Rate of minor access site or access-related vascular injury
Measured: up to 7 days and at 30 days
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Measured: up to 7 days and at 30 days)
all-cause death
all-cause death
Measured: up to 7 days and 30-day
death attributed to access-site or access-related complications
death attributed to access-site or access-related complications
Measured: up to 7 days and 30-day
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other
Measured: up to 7 days
access-site or access-related disabling/life- threatening bleeding according to BARC
access-site or access-related disabling/life- threatening bleeding according to BARC
Measured: up to 7 days and 30-day
access-site or access-related major bleeding according to BARC
access-site or access-related major bleeding according to BARC
Measured: up to 7 days and 30-day
access-site or access-related minor bleeding according to BARC
access-site or access-related minor bleeding according to BARC
Measured: up to 7 days and 30-day
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Measured: up to 7 days
Total number of blood transfusions because of access-site or access-related bleeding
Total number of blood transfusions because of access-site or access-related bleeding
Measured: up to 7 days
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Measured: 24 hours
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Measured: 24 hours
Length of postprocedural hospital stay
Length of postprocedural hospital stay
Measured: up to 7 days
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Measured: 24 hours
Need and number of additional unplanned VCDs
Need and number of additional unplanned VCDs
Measured: 24 hours
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start26 Jun 2020
- Primary completion7 Jul 2021
- Study completion4 Aug 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, single-center, prospective, open-label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Abdel-Wahab, PD Dr., Principal investigator, Herzzentrum Leipzig GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459208
- Sponsor's protocol ID
- 2020-0191
- Acronym
- CHOICE-CLOSURE
- Status last verified
- Sep 2021
- First submitted
- 26 Jun 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdel-Wahab M, Hartung P, Dumpies O, Obradovic D, Wilde J, Majunke N, Boekstegers P, Muller R, Seyfarth M, Vorpahl M, Kiefer P, Noack T, Leontyev S, Sandri M, Rotta Detto Loria J, Kitamura M, Borger MA, Funkat AK, Hohenstein S, Desch S, Holzhey D, Thiele H; CHOICE-CLOSURE Investigators. Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial. Circulation. 2022 Jan 18;145(3):170-183. doi: 10.1161/CIRCULATIONAHA.121.057856. Epub 2021 Nov 5.
PubMed 34738828
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04459208
- Acronym / sponsor ID
- CHOICE-CLOSURE / 2020-0191
- Conditions
- Aortic Valve Stenosis
- Keywords
- Vascular access site closure, Transcatheter aortic valve implantation, Vascular closure device, Vascular access-site injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 7 Jul 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.
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.
Detailed description
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator-initiated, single-center, prospective, open-label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Manta | Active comparator | Device: Mantaplug-based vascular closure |
| ProGlide | Active comparator | Device: ProGlidesuture-based vascular closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an indication for transfemoral TAVI as judged by the local heart team.
- Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
- The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.
Key exclusion criteria (10 listed)
- Vascular access site anatomy not suitable for percutaneous vascular closure.
- Vascular access site complications prior to the TAVI procedure.
- Known allergy or hypersensitivity to any VCD component.
- Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
- Absence of computed tomographic data of the access site before the procedure.
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 |
|---|---|---|
| Mantaplug-based vascular closure | Device | Manta |
| ProGlidesuture-based vascular closure | Device | ProGlide |
Primary outcome
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Time frame: up to 7 days
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
18 secondary outcomes
Rate of access-site or access-related vascular injury
Time frame: 30 days
Rate of major access-site or access-related vascular injury
Time frame: up to 7 days and at 30 days
Rate of minor access site or access-related vascular injury
Time frame: up to 7 days and at 30 days
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Time frame: up to 7 days and at 30 days)
all-cause death
Time frame: up to 7 days and 30-day
death attributed to access-site or access-related complications
Time frame: up to 7 days and 30-day
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Time frame: up to 7 days
access-site or access-related disabling/life- threatening bleeding according to BARC
Time frame: up to 7 days and 30-day
access-site or access-related major bleeding according to BARC
Time frame: up to 7 days and 30-day
access-site or access-related minor bleeding according to BARC
Time frame: up to 7 days and 30-day
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Time frame: up to 7 days
Total number of blood transfusions because of access-site or access-related bleeding
Time frame: up to 7 days
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Time frame: 24 hours
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Time frame: 24 hours
Length of postprocedural hospital stay
Time frame: up to 7 days
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time frame: 24 hours
Need and number of additional unplanned VCDs
Time frame: 24 hours
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Time frame: 24 hours
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 Sep 2021.
- Derived from this study: PubMed 34738828Abdel-Wahab M, Hartung P, Dumpies O, Obradovic D, Wilde J, Majunke N, Boekstegers P, Muller R, Seyfarth M, Vorpahl M, Kiefer P, Noack T, Leontyev S, Sandri M, Rotta Detto Loria J, Kitamura M, Borger MA, Funkat AK, Hohenstein S, Desch S, Holzhey D, Thiele H; CHOICE-CLOSURE Investigators. Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial. Circulation. 2022 Jan 18;145(3):170-183. doi: 10.1161/CIRCULATIONAHA.121.057856. Epub 2021 Nov 5.
Related trials for Aortic Valve Stenosis
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
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.
Mohamed Abdel-Wahab, PD Dr. principal investigator
Herzzentrum Leipzig GmbH
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 and ProGlide in people with Aortic Valve Stenosis, run by Helios Health Institute GmbH 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 3 inclusion and 10 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 Sep 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 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?
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition (time frame: up to 7 days). 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 NCT04459208, 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 29 Sep 2021.