Aortic Valve StenosisACCESS-TAVINCT05503199
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
A study testing Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo). and Combination of two ProGlides or ProStyles (Abbott Vascular). in people with Aortic Valve Stenosis, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to… 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?
- Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo). and Combination of two ProGlides or ProStyles (Abbott Vascular).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to 18 Apr 2024
- 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
- Age ≥ 18 years and able to give consent
- Patients with an indication for TF-TAVI as judged by the local multi-disciplinary heart team
- Feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems
- Written informed consent
Who cannot join
- Vascular access site anatomy not suitable for percutaneous vascular closure device
- Vascular access site complications prior to the TAVI procedure
- Known allergy or hypersensitivity to any component of the VCD
- Active bleeding or bleeding diathesis
- Absence of computed tomographic data of the access site before the procedure
- Systemic infection or local infection at or near the access site
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- Limited long-term prognosis due to other comorbid conditions
- Patient cannot adhere to or complete the trial protocol for any reason
- Pregnancy
- Participation in any other interventional trial
- Patients with mechanical heart valves in mitral position
- Patients with elevated international normalized ratio (INR) due to oral anticoagulation therapy requiring reversal of vitamin K antagonists prior to TAVI using prothrombin complex concentrate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.
Read the detailed description
Detailed information is provided elsewhere.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo)., Combination of two ProGlides or ProStyles (Abbott Vascular).
- Keywords
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), 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.
Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).Device
Combined suture- and plug-based VCD strategy after TF-TAVI.
Combination of two ProGlides or ProStyles (Abbott Vascular).Device
Pure suture-based VCD strategy after TF-TAVI.
| Study group | Role | What they receive |
|---|---|---|
| Combined suture- and plug-based VCD strategy | Experimental | 1 ProGlide or ProStyle + 1 Angio-Seal Receives: Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo). |
| Pure suture-based VCD strategy | Experimental | 2 ProGlides or ProStyles Receives: Device: Combination of two ProGlides or ProStyles (Abbott Vascular). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis.
The primary outcome measure is a combination of major or minor vascular and access-site-related complications or need for additional interventional (e.g. covered stent implantation) or surgical procedures related to vascular hemostasis according to updated VARC-3 criteria.
Measured: In-hospital, in average three days
Secondary outcomes (9)
Major or minor vascular and access-site-related complications after TF-TAVI.
Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria.
Measured: At 30-day follow-up
Individual components of the primary endpoint, namely 1) major or minor vascular and access-site-related complications, 2) need for additional interventional or surgical procedures related to vascular hemostasis.
Individual components of the primary endpoint according to VARC-3 criteria.
Measured: In-hospital (in average three days) and at 30-day follow-up
Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site.
Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site.
Measured: In-hospital (in average three days) and at 30-day follow-up
Any bleedings.
Any type of bleedings according to VARC-3 criteria.
Measured: In-hospital (in average three days) and at 30-day follow-up
Need for blood transfusions.
Need for blood transfusions for vascular access-site-related bleedings or vascular complications.
Measured: In-hospital (in average three days)
Percent diameter stenosis of vascular access vessel.
Percent diameter stenosis of vascular access vessel on post-procedural angiography.
Measured: Intra-procedural
All-cause mortality.
All-cause mortality according to VARC-3 criteria.
Measured: In-hospital (in average three days) and at 30-day follow-up
Length of post-procedural hospital stay.
Length of post-procedural hospital stay (days).
Measured: In-hospital (in average three days)
Time from VCD application to complete hemostasis.
Time from VCD application to complete hemostasis (seconds).
Measured: Intra-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Oct 2022
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Joner, MD, Principal investigator, Deutsches Herzzentrum MünchenTobias Rheude, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503199
- Sponsor's protocol ID
- GE IDE No. T00122
- Acronym
- ACCESS-TAVI
- Status last verified
- Apr 2024
- First submitted
- 2 Aug 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial
- ClinicalTrials.gov ID
- NCT05503199
- Acronym / sponsor ID
- ACCESS-TAVI / GE IDE No. T00122
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), Vascular Closure Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 16 Aug 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.
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.
Detailed description
Detailed information is provided elsewhere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined suture- and plug-based VCD strategy | Experimental | Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).1 ProGlide or ProStyle + 1 Angio-Seal |
| Pure suture-based VCD strategy | Experimental | Device: Combination of two ProGlides or ProStyles (Abbott Vascular).2 ProGlides or ProStyles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and able to give consent
- Patients with an indication for TF-TAVI as judged by the local multi-disciplinary heart team
- Feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems
- Written informed consent
Key exclusion criteria (12 listed)
- Vascular access site anatomy not suitable for percutaneous vascular closure device
- Vascular access site complications prior to the TAVI procedure
- Known allergy or hypersensitivity to any component of the VCD
- Active bleeding or bleeding diathesis
- 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 |
|---|---|---|
| Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).Combined suture- and plug-based VCD strategy after TF-TAVI. | Device | Combined suture- and plug-based VCD strategy |
| Combination of two ProGlides or ProStyles (Abbott Vascular).Pure suture-based VCD strategy after TF-TAVI. | Device | Pure suture-based VCD strategy |
Primary outcome
Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis.
Time frame: In-hospital, in average three days
The primary outcome measure is a combination of major or minor vascular and access-site-related complications or need for additional interventional (e.g. covered stent implantation) or surgical procedures related to vascular hemostasis according to updated VARC-3 criteria.
9 secondary outcomes
Major or minor vascular and access-site-related complications after TF-TAVI.
Time frame: At 30-day follow-up
Individual components of the primary endpoint, namely 1) major or minor vascular and access-site-related complications, 2) need for additional interventional or surgical procedures related to vascular hemostasis.
Time frame: In-hospital (in average three days) and at 30-day follow-up
Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site.
Time frame: In-hospital (in average three days) and at 30-day follow-up
Any bleedings.
Time frame: In-hospital (in average three days) and at 30-day follow-up
Need for blood transfusions.
Time frame: In-hospital (in average three days)
Percent diameter stenosis of vascular access vessel.
Time frame: Intra-procedural
All-cause mortality.
Time frame: In-hospital (in average three days) and at 30-day follow-up
Length of post-procedural hospital stay.
Time frame: In-hospital (in average three days)
Time from VCD application to complete hemostasis.
Time frame: Intra-procedural
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 23 Apr 2024.
- 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.
Michael Joner, MD principal investigator
Deutsches Herzzentrum München
Tobias Rheude, MD principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo). and Combination of two ProGlides or ProStyles (Abbott Vascular). in people with Aortic Valve Stenosis, run by Deutsches Herzzentrum Muenchen 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 4 inclusion and 12 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 23 Apr 2024. 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?
Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis. (time frame: In-hospital, in average three days). 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 23 Apr 2024.