Atrial FibrillationSAFE-VEINNCT04632641
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
A study testing Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES and Figure 8 Suture - LARGE-BORE PROCEDURES in people with Atrial Fibrillation and Atrial Flutter, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Heart Block
- What is being tested?
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES and Figure 8 Suture - LARGE-BORE PROCEDURES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2021to 31 Dec 2023
- 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
- Large-bore (>13F) Venous Access Procedures Inclusion Criteria:
- All patients 18 years and older who are undergoing any of the following: WATCHMAN® device placement, atrial fibrillation ablation using cryoballoon or laser balloon, leadless pacemaker, Pulmonary embolism thrombectomy (Inari FlowTriever system), MitraClip transcatheter mitral valve repair at Aurora St. Luke's Medical Center from date of IRB (Institutional Review Board) approval through December 2022. All arterial line access should be radial.
Who cannot join
- Large-bore (>13F) Venous Access Procedures Exclusion Criteria:
- Patients in whom introducer sheaths >25F were used in the vein during the catheterization procedure.
- Patients with small femoral arteries or veins (< 5 mm in diameter).
- Patients with access sites in vascular grafts.
- Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access.
- Patients who have complications during the procedure not related to the Perclose ProGlide SMC closure device
Show all 17Show fewer
- The physician determines that they must use an alternate method as the primary venous closure method other than that which the patient was randomized to
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
- Known history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
- Severe co-existing morbidities with life expectancy less than 12 months
- Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
- Planned femoral venous or arterial access within next 30 days
- Unable to routinely walk at least 20 ft. without assistance
- LMWH (low molecular weight heparin) within 8 hours before or after procedure
- Pregnant and/or lactating women
- Extreme morbid obesity (BMI > 40 kg/m2) or underweight (BMI < 20 kg/m2)
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial: A Randomized, Prospective Study of the Safety and Efficacy of Venous Closure Device Compared to Conventional Closure Strategies in Post Venous Access Procedures
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures.
Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.
Read the detailed description
This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC (Aurora St. Luke's Medical Center):
Large-Bore Procedures >13 F
- WATCHMAN® device placement
- Atrial fibrillation/flutter/SVT (supraventricular tachycardia) ablation using cryoballoon or laser balloon
- Leadless pacemaker
- Pulmonary embolism thrombectomy (Inari FlowTriever system)
- MitraClip transcatheter mitral valve repair
RANDOMIZATION:
Patients will be randomized into one of two venous closure groups after a clean stick has been achieved with no complications:
Large-bore (14F-25F) venous access group (1:1)
- Perclose ProGlide SMC
- Figure 8 suture
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis, Mitral Valve Repair, Sinus Node Dysfunction
- Being tested
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES, Figure 8 Suture - LARGE-BORE PROCEDURES
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism, Thrombosis, Sick Sinus Syndrome, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURESDevice
The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
Figure 8 Suture - LARGE-BORE PROCEDURESOther
A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
| Study group | Role | What they receive |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Experimental | Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F. Receives: Device: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Active comparator | Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F. Receives: Other: Figure 8 Suture - LARGE-BORE PROCEDURES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve Hemostasis
The elapsed time between "device" removal and first observed and confirmed venous hemostasis
Measured: Day 1
Time to Ambulate
The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites.
Measured: Day 1
Secondary outcomes (5)
Time to Discharge (TTD)/Length of Stay (LOS)
The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay.
Measured: up to 5 days post procedure
Post Procedure Major Bleeding
Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.
Measured: up to 30 days post procedure
Minor Bleeding
Any bleeding that does not meet the criteria for major bleeding
Measured: up to 30 days post procedure
Access Site Complications
Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula
Measured: up to 30 days post procedure
Mortality
Mortality due to vascular complications
Measured: up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start23 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad E Mortada, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632641
- Sponsor's protocol ID
- 20-235
- Acronym
- SAFE-VEIN
- Status last verified
- Apr 2024
- First submitted
- 11 Nov 2020
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ali M, Masood F, Erickson L, Adefisoye J, Kanani J, Walczak S, Ajam T, Kieu A, Premjee M, Jan MF, Allaqaband SQ, Bajwa T, Khitha J, Zilinski J, Jahangir A, Djelmami-Hani M, Sra J, Niazi I, Mortada ME. Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device. Catheter Cardiovasc Interv. 2024 Oct;104(4):820-828. doi: 10.1002/ccd.31173. Epub 2024 Aug 1.
PubMed 39087741
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial: A Randomized, Prospective Study of the Safety and Efficacy of Venous Closure Device Compared to Conventional Closure Strategies in Post Venous Access Procedures
- ClinicalTrials.gov ID
- NCT04632641
- Acronym / sponsor ID
- SAFE-VEIN / 20-235
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis, Mitral Valve Repair, Sinus Node Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures.
Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.
Detailed description
This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC (Aurora St. Luke's Medical Center):
Large-Bore Procedures >13 F
- WATCHMAN® device placement
- Atrial fibrillation/flutter/SVT (supraventricular tachycardia) ablation using cryoballoon or laser balloon
- Leadless pacemaker
- Pulmonary embolism thrombectomy (Inari FlowTriever system)
- MitraClip transcatheter mitral valve repair
RANDOMIZATION:
Patients will be randomized into one of two venous closure groups after a clean stick has been achieved with no complications:
Large-bore (14F-25F) venous access group (1:1)
- Perclose ProGlide SMC
- Figure 8 suture
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Experimental | Device: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURESPerclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F. |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Active comparator | Other: Figure 8 Suture - LARGE-BORE PROCEDURESFigure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients 18 years and older who are undergoing any of the following: WATCHMAN® device placement, atrial fibrillation ablation using cryoballoon or laser balloon, leadless pacemaker, Pulmonary embolism thrombectomy (Inari FlowTriever system), MitraClip transcatheter mitral valve repair at Aurora St. Luke's Medical Center from date of IRB (Institutional Review Board) approval through December 2022. All arterial line access should be radial.
Key exclusion criteria (17 listed)
- Patients in whom introducer sheaths >25F were used in the vein during the catheterization procedure.
- Patients with small femoral arteries or veins (< 5 mm in diameter).
- Patients with access sites in vascular grafts.
- Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access.
- Patients who have complications during the procedure not related to the Perclose ProGlide SMC closure device
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 Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURESThe Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis. | Device | Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES |
| Figure 8 Suture - LARGE-BORE PROCEDURESA figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures. | Other | Figure 8 Suture - LARGE-BORE PROCEDURES |
Primary outcome
Time to Achieve Hemostasis
Time frame: Day 1
The elapsed time between "device" removal and first observed and confirmed venous hemostasis
Time to Ambulate
Time frame: Day 1
The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites.
5 secondary outcomes
Time to Discharge (TTD)/Length of Stay (LOS)
Time frame: up to 5 days post procedure
Post Procedure Major Bleeding
Time frame: up to 30 days post procedure
Minor Bleeding
Time frame: up to 30 days post procedure
Access Site Complications
Time frame: up to 30 days post procedure
Mortality
Time frame: up to 30 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39087741Ali M, Masood F, Erickson L, Adefisoye J, Kanani J, Walczak S, Ajam T, Kieu A, Premjee M, Jan MF, Allaqaband SQ, Bajwa T, Khitha J, Zilinski J, Jahangir A, Djelmami-Hani M, Sra J, Niazi I, Mortada ME. Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device. Catheter Cardiovasc Interv. 2024 Oct;104(4):820-828. doi: 10.1002/ccd.31173. Epub 2024 Aug 1.
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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.
Mohammad E Mortada, 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 Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES and Figure 8 Suture - LARGE-BORE PROCEDURES in people with Atrial Fibrillation and Atrial Flutter, 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 2 inclusion and 17 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 3 Oct 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 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 May 2024). 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?
Time to Achieve Hemostasis (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT04632641, which also lists 1 linked publication.
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 3 Oct 2024.