Transcatheter Aortic Valve ReplacementNCT06871774
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
A study testing Single Perclose Pro vascular closure device and Dual Perclose vascular closure device in people with Transcatheter Aortic Valve Replacement, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- Single Perclose Pro vascular closure device and Dual Perclose vascular closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient age 18 or older
- Transfemoral transcatheter aortic valve replacement (TAVR)
- Implantation of CoreValve replacement valve
- Access using 14 French sheaths
- English speaking
Who cannot join
- Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access.
- Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access.
- Vascular Access Complications: Patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
- Arterial or Venous Issues: Patients with small femoral arteries or veins (<5 mm in diameter), patients with access sites located in vascular grafts.
- Body Composition: Patients with BMI >35
- Cardiac Vasculature: Patients with excess calcification of vessels as determined by echocardiography and/or CT angiography
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- Infection or Inflammation: Active systemic or cutaneous infection or inflammation in the vicinity of the groin.
- Coagulation and Hematological Disorders: Known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count <100,000 cells/mm³. Pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids.
- Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
- Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
- Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
- Pregnancy and Lactation: Pregnant or lactating women.
- Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
- Contraindications: Patients with contraindications for the use of Perclose device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Suhail Q Allaqaband, MD, 414-649-3491, suhail.allaqaband@aah.org
About this study
Official title: Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.
Read the detailed description
This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- Single Perclose Pro vascular closure device, Dual Perclose vascular closure device
- Keywords
- aortic valve diseases, Perclose device, arteriotomy
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Perclose Pro vascular closure deviceDevice
Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.
Dual Perclose vascular closure deviceDevice
Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.
| Study group | Role | What they receive |
|---|---|---|
| Single Device | Experimental | A single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis. Receives: Device: Single Perclose Pro vascular closure device |
| Two device | Active comparator | Two Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis. Receives: Device: Dual Perclose vascular closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Vascular Complications
Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization.
Measured: Day 5 post-procedure
Number of Patients With Life-threatening bleeding
Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure.
Measured: Hour 24 post-procedure
Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition
Number of subjects in each group experiencing bleeding complications related to the TAVR procedure that do not meet the criteria for life-threatening bleeding but still result in significant clinical concern within 24 hours of the index procedure.
Measured: Hour 24 post-procedure
Time to Hemostasis
For each subject, time elapsed from initial deployment of the initial one or two Perclose devices (depending on assigned group) to complete hemostasis of the femoral access site. Measured in seconds.
Measured: 1 hour post procedure
Secondary outcomes (4)
Additional Closure Device Use
Number of subjects requiring use of additional closure devices beyond the initial closure strategy required to achieve hemostasis at the femoral access site within 24 hours post-procedure. The number and type of devices will be recorded for each subject.
Measured: Hour 24 post-procedure
In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions
Number of subjects in each group experiencing severe vascular complications that necessitate either percutaneous procedures or surgical interventions during the index hospitalization.
Measured: Day 5 post-procedure
Number of Patients With Limb Ischemia Related to TAVR During Index Admission
Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure between the TAVR procedure and discharge.
Measured: Day 5 post-procedure
Limb Ischemia Related to TAVR
Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure monitored within 30 days post procedure.
Measured: Day 30 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start16 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suhail Q Allaqaband, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871774
- Sponsor's protocol ID
- IRB00124842
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06871774
- Acronym / sponsor ID
- IRB00124842
- Conditions
- Transcatheter Aortic Valve Replacement
- Keywords
- aortic valve diseases, Perclose device, arteriotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Mar 2025 (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.
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.
Detailed description
This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Device | Experimental | Device: Single Perclose Pro vascular closure deviceA single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis. |
| Two device | Active comparator | Device: Dual Perclose vascular closure deviceTwo Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age 18 or older
- Transfemoral transcatheter aortic valve replacement (TAVR)
- Implantation of CoreValve replacement valve
- Access using 14 French sheaths
- English speaking
Key exclusion criteria (14 listed)
- Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access.
- Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access.
- Vascular Access Complications: Patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
- Arterial or Venous Issues: Patients with small femoral arteries or veins (<5 mm in diameter), patients with access sites located in vascular grafts.
- Body Composition: Patients with BMI >35
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 |
|---|---|---|
| Single Perclose Pro vascular closure deviceUse of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath. | Device | Single Device |
| Dual Perclose vascular closure deviceUse of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath. | Device | Two device |
Primary outcome
Number of Patients With Vascular Complications
Time frame: Day 5 post-procedure
Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization.
Number of Patients With Life-threatening bleeding
Time frame: Hour 24 post-procedure
Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure.
Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition
Time frame: Hour 24 post-procedure
Number of subjects in each group experiencing bleeding complications related to the TAVR procedure that do not meet the criteria for life-threatening bleeding but still result in significant clinical concern within 24 hours of the index procedure.
Time to Hemostasis
Time frame: 1 hour post procedure
For each subject, time elapsed from initial deployment of the initial one or two Perclose devices (depending on assigned group) to complete hemostasis of the femoral access site. Measured in seconds.
4 secondary outcomes
Additional Closure Device Use
Time frame: Hour 24 post-procedure
In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions
Time frame: Day 5 post-procedure
Number of Patients With Limb Ischemia Related to TAVR During Index Admission
Time frame: Day 5 post-procedure
Limb Ischemia Related to TAVR
Time frame: Day 30 post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- 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.
Suhail Q Allaqaband, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Perclose Pro vascular closure device and Dual Perclose vascular closure device in people with Transcatheter Aortic Valve Replacement, run by Wake Forest University Health Sciences 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 5 inclusion and 14 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suhail Q Allaqaband, MD (414-649-3491, suhail.allaqaband@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Vascular Complications (time frame: Day 5 post-procedure). The study lists 4 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 25 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.