Severe Aortic StenosisSingleNCT06173115
Comparison of a Single Versus Double Perclose Technique for TAVR
A study testing Perclose Proglide system in people with Severe Aortic Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 25 sites in China.
Trial summary
Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- Perclose Proglide system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- 25 sitesChina
- Study dates
- 23 Jan 2024to 19 Mar 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations.
Who cannot join
- Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman ageable 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; life expectancy of <6 months because of noncardiac conditions; patients who can-not adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital of Central South University
Changshacun, Henan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Fujian Provincial Hospital
Fuzhou, Fujian
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Huzhou Central Hospital
Huzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
The First Hospital of Lanzhou University
Lanzhou, Gansu
Ningbo Medical Center Li Huili Hospital
Ningbo, Zhejiang
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Qingdao Municipal Hospital
Qingdao, Shandong
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Yulin First People's Hospital
Yulin, Guangxi
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
Henan Provincial Chest Hospital
Zhengzhou, Henan
About this study
Official title: The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial
Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement.
One of the critical components of procedural success in a transfemoral approach is access site management, as vascular complications strongly correlate with adverse outcomes. When major vascular complications occur, there are higher rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as a significantly higher rate of 30-day and 1-year mortality. In recent years, a "preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. This allows for arterial closure after dilation to sizing up to larger bore access sheaths that accommodate valve delivery systems. The sutures are subsequently harvested and tightened to close the large bore arteriotomy site at the end of the case. It has been demonstrated that the use of two Perclose devices, or double Perclose closure, is an effective closure technique with a low rate of vascular complications. A large number of TAVR centers have adopted this method for large-bore vascular closure. In the past, there have been few investigations comparing the utilization of a single Perclose device compared to a double Perclose technique. There are numerous theoretical advantages to the use of a single device, which include decreased procedural cost and procedural time. The investigation aimed to determine if there are clinical benefits as well using the single Perclose approach.
Read the detailed description
SINGLE-CLOSURE (The utilization of Single versus double perclose devices for transfemoral aortIc valve replacement access site Closure) is an investigator-initiated, open-label, multicenter, randomized controlled trial. The study was approved by the local ethics committees of all participating centers, and each patient provided written informed consent for inclusion in the trial. Data management and analysis was performed by an independent data coordinating center, with oversight from a steering committee. The members of the steering committee had full access to the data and vouch for the accuracy and complete- ness of the data and the analyses. The data that support the findings of this study are available from the corresponding author on reasonable request. Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations. Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman-ageable 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; life expectancy of <6 months because of noncardiac conditions; patients who cannot adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.
The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria. The end point was assessed during index hospitalization. Relationship to the access site was deter- mined according to the site used for the large-bore vascular access sheath.
Secondary end points included the rate of the primary end point at 30 days; components of the primary end point in-hospital and at 30 days; in-hospital and 30-day major and minor vascular complications; unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site; in-hospital and 30-day access site- or access-related minor, major, and disabling or life threatening bleeding; need for blood transfusion for access site- or access-related bleeding or vascular complications; rate of VCD failure, defined as the failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment (other than manual compression or adjunctive endovascular ballooning); in-hospital and 30-day all-cause death; in-hospital and 30-day death attributed to access site or access-related complications; need and number of additional unplanned VCDs; time to hemostasis, defined as the time from VCD application to complete hemostasis; and the length of postprocedural hospital stay.
- Conditions
- Severe Aortic Stenosis
- Being tested
- Perclose Proglide system
- Keywords
- transcatheter aortic valve replacement, vascular closure devices, randomized control trial
- 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.
Perclose Proglide systemDevice
"Preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site.
| Study group | Role | What they receive |
|---|---|---|
| Double Perclose device | Active comparator | Double Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures Receives: Device: Perclose Proglide system |
| Single Perclose device | Experimental | Single Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures Receives: Device: Perclose Proglide system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria
- Aortic dissection or aortic rupture
- Vascular (arterial or venous) injury (perforation, rupture, dissection, stenosis, ischaemia, arterial or venous thrombosis including pulmonary embolism, arteriovenous fistula, pseudoaneurysm, haematoma, retroperitoneal haematoma, infection) or compartment syndrome resulting in death, VARC type >_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment;
- Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible endorgan damage;
- Unplanned endovascular or surgical intervention resulting in death, VARC type >_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment;
- Closure device failure c resulting in death, VARC type >_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
Measured: The end point was assessed during index hospitalization
Secondary outcomes (9)
The rate of the primary end point at 30 days
the rate of access site or access-related major and minor vascular complications at 30 days
Measured: 30 days
Components of the primary end point in-hospital and at 30 days
Components of the rate of access site or access-related major and minor vascular complications at 30 days
Measured: 30 days
In-hospital and 30-day major and minor vascular complications
In-hospital and 30-day major and minor vascular complications
Measured: 30 days
Unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site at 30 days
Measured: 30 days
in-hospital and 30-day access site- or access-related minor, major, and disabling or life- threatening bleeding; need for blood transfusion for access site or access related bleeding or vascular complications
in-hospital and 30-day access site- or access-related minor, major, and disabling or life- threatening bleeding; need for blood transfusion for access site or access related bleeding or vascular complications
Measured: 30 days
Rate of VCD failure, defined as the failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment (other than manual compression or adjunctive endovascular ballooning)
Rate of VCD failure, defined as the failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment (other than manual compression or adjunctive endovascular ballooning) at 30 days
Measured: 30 days
In-hospital and 30-day all-cause death; in-hospital and 30-day death attributed to access site- access-related complications; need and number of additional unplanned VCDs
In-hospital and 30-day all-cause death; in-hospital and 30-day death attributed to access site- access-related complications; need and number of additional unplanned VCDs
Measured: 30 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 at 30 days
Measured: 30 days
The length of postprocedural hospital stay
The length of postprocedural hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start23 Jan 2024
- Primary completion13 Feb 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic 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
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, PhD, Study chair, Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173115
- Sponsor's protocol ID
- SAHZJU CT022
- Acronym
- Single
- Status last verified
- Jul 2026
- First submitted
- 30 Oct 2023
- Last updated
- 2 Oct 2026
- Results posted
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06173115
- Acronym / sponsor ID
- Single / SAHZJU CT022
- Conditions
- Severe Aortic Stenosis
- Keywords
- transcatheter aortic valve replacement, vascular closure devices, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 15 Dec 2023 (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.
Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement.
One of the critical components of procedural success in a transfemoral approach is access site management, as vascular complications strongly correlate with adverse outcomes. When major vascular complications occur, there are higher rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as a significantly higher rate of 30-day and 1-year mortality. In recent years, a "preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. This allows for arterial closure after dilation to sizing up to larger bore access sheaths that accommodate valve delivery systems. The sutures are subsequently harvested and tightened to close the large bore arteriotomy site at the end of the case. It has been demonstrated that the use of two Perclose devices, or double Perclose closure, is an effective closure technique with a low rate of vascular complications. A large number of TAVR centers have adopted this method for large-bore vascular closure. In the past, there have been few investigations comparing the utilization of a single Perclose device compared to a double Perclose technique. There are numerous theoretical advantages to the use of a single device, which include decreased procedural cost and procedural time. The investigation aimed to determine if there are clinical benefits as well using the single Perclose approach.
Detailed description
SINGLE-CLOSURE (The utilization of Single versus double perclose devices for transfemoral aortIc valve replacement access site Closure) is an investigator-initiated, open-label, multicenter, randomized controlled trial. The study was approved by the local ethics committees of all participating centers, and each patient provided written informed consent for inclusion in the trial. Data management and analysis was performed by an independent data coordinating center, with oversight from a steering committee. The members of the steering committee had full access to the data and vouch for the accuracy and complete- ness of the data and the analyses. The data that support the findings of this study are available from the corresponding author on reasonable request. Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations. Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman-ageable 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; life expectancy of <6 months because of noncardiac conditions; patients who cannot adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.
The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria. The end point was assessed during index hospitalization. Relationship to the access site was deter- mined according to the site used for the large-bore vascular access sheath.
Secondary end points included the rate of the primary end point at 30 days; components of the primary end point in-hospital and at 30 days; in-hospital and 30-day major and minor vascular complications; unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site; in-hospital and 30-day access site- or access-related minor, major, and disabling or life threatening bleeding; need for blood transfusion for access site- or access-related bleeding or vascular complications; rate of VCD failure, defined as the failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment (other than manual compression or adjunctive endovascular ballooning); in-hospital and 30-day all-cause death; in-hospital and 30-day death attributed to access site or access-related complications; need and number of additional unplanned VCDs; time to hemostasis, defined as the time from VCD application to complete hemostasis; and the length of postprocedural hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Perclose device | Active comparator | Device: Perclose Proglide systemDouble Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures |
| Single Perclose device | Experimental | Device: Perclose Proglide systemSingle Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations.
Key exclusion criteria (1 listed)
- Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman ageable 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; life expectancy of <6 months because of noncardiac conditions; patients who can-not adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.
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 |
|---|---|---|
| Perclose Proglide system"Preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. | Device | Double Perclose device, Single Perclose device |
Primary outcome
The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria
Time frame: The end point was assessed during index hospitalization
1. Aortic dissection or aortic rupture 2. Vascular (arterial or venous) injury (perforation, rupture, dissection, stenosis, ischaemia, arterial or venous thrombosis including pulmonary embolism, arteriovenous fistula, pseudoaneurysm, haematoma, retroperitoneal haematoma, infection) or compartment syndrome resulting in death, VARC type >_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment; 3. Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible endorgan damage; 4. Unplanned endovascular or surgical intervention resulting in death, VARC type >_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment; 5. Closure device failure c resulting in death, VARC type >_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
9 secondary outcomes
The rate of the primary end point at 30 days
Time frame: 30 days
Components of the primary end point in-hospital and at 30 days
Time frame: 30 days
In-hospital and 30-day major and minor vascular complications
Time frame: 30 days
Unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Time frame: 30 days
in-hospital and 30-day access site- or access-related minor, major, and disabling or life- threatening bleeding; need for blood transfusion for access site or access related bleeding or vascular complications
Time frame: 30 days
Rate of VCD failure, defined as the failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment (other than manual compression or adjunctive endovascular ballooning)
Time frame: 30 days
In-hospital and 30-day all-cause death; in-hospital and 30-day death attributed to access site- access-related complications; need and number of additional unplanned VCDs
Time frame: 30 days
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time frame: 30 days
The length of postprocedural hospital stay
Time frame: 30 days
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 2 Oct 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. This study is not recruiting at the moment.
Jianan Wang, PhD study chair
Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perclose Proglide system in people with Severe Aortic Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 25 sites in China.
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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. 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?
The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria (time frame: The end point was assessed during index hospitalization). 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 2 Oct 2026.