Transcatheter Aortic Valve ReplacementTAVI-CLOSENCT06983938
This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement
A study testing Double Perclose Proglide and Single Perclose Proglide plus Angioseal in people with Transcatheter Aortic Valve Replacement and Closure Technique, run by Baylor Research Institute at 1 site in United States.
Trial summary
This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Closure Technique
- What is being tested?
- Double Perclose Proglide and Single Perclose Proglide plus Angioseal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 old
- Planned to undergo transcatheter aortic valve replacement via femoral access
- Able to provide written informed consent prior to study participation
Who cannot join
- Non-femoral access
- Previous repair or intervention of the common femoral artery
- Previous pseudoaneurysm of the common femoral artery
- Children below 18 years, prisoners, and patients who are unable to provide consent are excluded.
- In another research study that has not granted permission to dual-enroll.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
About this study
Official title: Randomized Trial Comparing Dual Perclose Vs Single Angioseal And Perclose in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement
This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.
Read the detailed description
This is a prospective, randomized, parallel, open-label, single-center, non-inferiority study.
Approximately 90 patients undergoing Transcatheter Aortic Valve Replacement with femoral access will be randomized in a 1:1 fashion to receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal for closure.
The primary end point of this study is the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication. Secondary end points include periprocedural complications (such as acute vessel closure, leg embolization and perforation), procedural characteristics (total duration, fluoroscopy time, contrast volume, length of hospital stay), and cost of hospitalization. A routine follow-up visit assessment will be performed at 30 days in the valve clinic and the assessment will include: any clinical change, re-interventions, and peripheral pulse evaluation.
- Being tested
- Double Perclose Proglide, Single Perclose Proglide plus Angioseal
- Keywords
- Transcatheter aortic valve replacement, Perclose Proglide, Angioseal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Perclose ProglideDevice
Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
Single Perclose Proglide plus AngiosealDevice
Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
| Study group | Role | What they receive |
|---|---|---|
| Dual Perclose Proglide | Active comparator | Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices. Receives: Device: Double Perclose Proglide |
| Single Perclose Proglide plus Angioseal | Active comparator | Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device. Receives: Device: Single Perclose Proglide plus Angioseal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Access-related Bleeding and Vascular Complications
Primary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria.
Measured: Periprocedural through hospital discharge, an average of 1.5 days
Secondary outcomes (8)
Periprocedural Complications
A secondary endpoint will be the number of participants with periprocedural complications including acute vessel closure, leg embolization, or vessel perforation/dissection.
Measured: Periprocedural through hospital discharge, an average of 1.5 days
Procedural Total Duration
Total procedure duration from procedure start to completion.
Measured: Periprocedural, around 1.5 hours
Fluoroscopy Time
Total fluoroscopy time will be measured from procedure start to completion.
Measured: Periprocedural, around 1.5 hours
Contrast Volume
Total contrast volume will be measured from the start of the procedure until completion.
Measured: Periprocedural, about 1.5 hours
Length of Hospital Stay
The length of the hospital stay will be collected.
Measured: From patient arrival until discharge, about 1.5 days
Cost of Hospital Stay
The cost of the hospital stay will be collected.
Measured: Patient arrival to discharge, about 1.5 days
Minor Vascular Complications
The number of participants with minor vascular complications will be collected
Measured: Periprocedural, about 1.5 hours
Need for Secondary Closure Device
The number of participants with the need for a secondary closure device will be collected.
Measured: Periprocedural, about 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start12 Feb 2025
- Primary completion13 Aug 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ReplacementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983938
- Sponsor's protocol ID
- 024-458
- Acronym
- TAVI-CLOSE
- Status last verified
- Sep 2025
- First submitted
- 6 May 2025
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kiramijyan S, Magalhaes MA, Ben-Dor I, Koifman E, Escarcega RO, Baker NC, Torguson R, Okubagzi P, Bernardo NL, Satler LF, Pichard AD, Waksman R. The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement. EuroIntervention. 2016 May 17;12(1):88-93. doi: 10.4244/EIJV12I1A16.
PubMed 27173868Ko TY, Kao HL, Liu YJ, Yeh CF, Huang CC, Chen YH, Hung CS, Chan CY, Lin LC, Chen YS, Lin MS. Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement. Int J Cardiol. 2019 Oct 15;293:76-79. doi: 10.1016/j.ijcard.2019.05.055. Epub 2019 May 23.
PubMed 31155328Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 12.
PubMed 31713996
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Dual Perclose Vs Single Angioseal And Perclose in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT06983938
- Acronym / sponsor ID
- TAVI-CLOSE / 024-458
- Keywords
- Transcatheter aortic valve replacement, Perclose Proglide, Angioseal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.
Detailed description
This is a prospective, randomized, parallel, open-label, single-center, non-inferiority study.
Approximately 90 patients undergoing Transcatheter Aortic Valve Replacement with femoral access will be randomized in a 1:1 fashion to receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal for closure.
The primary end point of this study is the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication. Secondary end points include periprocedural complications (such as acute vessel closure, leg embolization and perforation), procedural characteristics (total duration, fluoroscopy time, contrast volume, length of hospital stay), and cost of hospitalization. A routine follow-up visit assessment will be performed at 30 days in the valve clinic and the assessment will include: any clinical change, re-interventions, and peripheral pulse evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Perclose Proglide | Active comparator | Device: Double Perclose ProglideUpon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices. |
| Single Perclose Proglide plus Angioseal | Active comparator | Device: Single Perclose Proglide plus AngiosealUpon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Planned to undergo transcatheter aortic valve replacement via femoral access
- Able to provide written informed consent prior to study participation
Key exclusion criteria (5 listed)
- Non-femoral access
- Previous repair or intervention of the common femoral artery
- Previous pseudoaneurysm of the common femoral artery
- Children below 18 years, prisoners, and patients who are unable to provide consent are excluded.
- In another research study that has not granted permission to dual-enroll.
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 |
|---|---|---|
| Double Perclose ProglideUpon completion of valve replacement, closure will proceed using two Perclose Proglide devices. | Device | Dual Perclose Proglide |
| Single Perclose Proglide plus AngiosealUpon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device. | Device | Single Perclose Proglide plus Angioseal |
Primary outcome
Main Access-related Bleeding and Vascular Complications
Time frame: Periprocedural through hospital discharge, an average of 1.5 days
Primary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria.
8 secondary outcomes
Periprocedural Complications
Time frame: Periprocedural through hospital discharge, an average of 1.5 days
Procedural Total Duration
Time frame: Periprocedural, around 1.5 hours
Fluoroscopy Time
Time frame: Periprocedural, around 1.5 hours
Contrast Volume
Time frame: Periprocedural, about 1.5 hours
Length of Hospital Stay
Time frame: From patient arrival until discharge, about 1.5 days
Cost of Hospital Stay
Time frame: Patient arrival to discharge, about 1.5 days
Minor Vascular Complications
Time frame: Periprocedural, about 1.5 hours
Need for Secondary Closure Device
Time frame: Periprocedural, about 1.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27173868Kiramijyan S, Magalhaes MA, Ben-Dor I, Koifman E, Escarcega RO, Baker NC, Torguson R, Okubagzi P, Bernardo NL, Satler LF, Pichard AD, Waksman R. The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement. EuroIntervention. 2016 May 17;12(1):88-93. doi: 10.4244/EIJV12I1A16.
- Background: PubMed 31155328Ko TY, Kao HL, Liu YJ, Yeh CF, Huang CC, Chen YH, Hung CS, Chan CY, Lin LC, Chen YS, Lin MS. Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement. Int J Cardiol. 2019 Oct 15;293:76-79. doi: 10.1016/j.ijcard.2019.05.055. Epub 2019 May 23.
- Background: PubMed 31713996Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 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?
A study testing Double Perclose Proglide and Single Perclose Proglide plus Angioseal in people with Transcatheter Aortic Valve Replacement and Closure Technique, run by Baylor Research Institute at 1 site in United States.
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 5 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 25 Jun 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Main Access-related Bleeding and Vascular Complications (time frame: Periprocedural through hospital discharge, an average of 1.5 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 NCT06983938, which also lists 3 linked publications.
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 25 Jun 2026.