Vascular ClosurePERCLOSE-LPNCT06837870
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
A study testing percutaneous suture mediated closure and Figure of Eight Suture in people with Vascular Closure and Pacemaker Implantation, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- What is being tested?
- percutaneous suture mediated closure and Figure of Eight Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 1 Jan 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
- Patients aged 18 and older
- Patients undergoing leadless pacemaker implant at UMass Chan Medical Center
- Subjects able to understand and provide written informed consent.
Who cannot join
- Patients who are pregnant
- Patents who are not able to ambulate prior to the procedure
- Other conditions that, in the opinion of the investigator constitute a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
- Prisoners or wards of the state.
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
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A Randomized Comparison of Percutaneous Closure to a Figure-of-eight Suture With Manual Compression for Hemostasis of Large-bore Access for Leadless Pacemaker Implantation
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker implantation.
- Conditions
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- Being tested
- percutaneous suture mediated closure, Figure of Eight Suture
- Keywords
- perclose, percutaneous closure, leadless pacemaker, venous access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous suture mediated closureDevice
Also called PerClose, ProStyle
Vascular closure with a commercially available SMC device.
Figure of Eight SutureDevice
Also called Fo8
Manual Compression with Figure of Eight Suture (control).
| Study group | Role | What they receive |
|---|---|---|
| SMC | Experimental | Percutaneous suture mediated closure group Receives: Device: percutaneous suture mediated closure |
| MC | Active comparator | Manual Compression (with a figure-of-eight) closure group (i.e., control). Receives: Device: Figure of Eight Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hemostasis
Time from sheath pull to hemostasis.
Measured: During the procedure.
Secondary outcomes (5)
Time to discharge eligibility
Time from sheath pull to eligibility for discharge.
Measured: Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.
Major access related complications
Composite and individual access related complications
Measured: 0 and 30 days
Minor access related complications
Composite and individual access related complications
Measured: 0 and 30 days
Patient reported outcomes
Patient reported outcomes of both a pain and satisfaction ascertained by a questionnaire reported as a total/composite score of all questions, as well as the score for each individual question on the questionnaire (rated on a likert scale).
Measured: 0 and 30 days
Costs
Direct and indirect procedure and peri-procedural cost data
Measured: 0 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start11 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ClosureStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soroosh Kiani, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837870
- Sponsor's protocol ID
- STUDY00002172
- Acronym
- PERCLOSE-LP
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2025
- Last updated
- 27 Mar 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Percutaneous Closure to a Figure-of-eight Suture With Manual Compression for Hemostasis of Large-bore Access for Leadless Pacemaker Implantation
- ClinicalTrials.gov ID
- NCT06837870
- Acronym / sponsor ID
- PERCLOSE-LP / STUDY00002172
- Conditions
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- Keywords
- perclose, percutaneous closure, leadless pacemaker, venous access
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Feb 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.
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMC | Experimental | Device: percutaneous suture mediated closurePercutaneous suture mediated closure group |
| MC | Active comparator | Device: Figure of Eight SutureManual Compression (with a figure-of-eight) closure group (i.e., control). |
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 aged 18 and older
- Patients undergoing leadless pacemaker implant at UMass Chan Medical Center
- Subjects able to understand and provide written informed consent.
Key exclusion criteria (4 listed)
- Patients who are pregnant
- Patents who are not able to ambulate prior to the procedure
- Other conditions that, in the opinion of the investigator constitute a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
- Prisoners or wards of the state.
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 |
|---|---|---|
| percutaneous suture mediated closureAlso: PerClose, ProStyleVascular closure with a commercially available SMC device. | Device | SMC |
| Figure of Eight SutureAlso: Fo8Manual Compression with Figure of Eight Suture (control). | Device | MC |
Primary outcome
Time to Hemostasis
Time frame: During the procedure.
Time from sheath pull to hemostasis.
5 secondary outcomes
Time to discharge eligibility
Time frame: Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.
Major access related complications
Time frame: 0 and 30 days
Minor access related complications
Time frame: 0 and 30 days
Patient reported outcomes
Time frame: 0 and 30 days
Costs
Time frame: 0 and 30 days
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 27 Mar 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.
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 percutaneous suture mediated closure and Figure of Eight Suture in people with Vascular Closure and Pacemaker Implantation, run by University of Massachusetts, Worcester 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 4 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 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?
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?
Time to Hemostasis (time frame: During the procedure.). 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 27 Mar 2026.