ArrhythmiaNCT04904809

Perclose Multi-Access Duplex Ultrasound (DUS) Study

A study testing Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System in people with Arrhythmia, run by Abbott Medical Devices at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arrhythmia
What is being tested?: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 2 sitesUnited States
Study dates: 1 Sep 2021to 27 May 2022
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
Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein
All the access sites are planned to be treated with Perclose SMC
Written informed consent is obtained prior to the procedure

Who cannot join

Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure
Prior ipsilateral deep vein thrombosis within 6 months
International Normalization Ratio >3.5 for patients on warfarin
Subject who is not able to ambulate pre-procedure
Women who are pregnant (based on site standard pre-procedure pregnancy test)
Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Emory University Hospital
Atlanta, Georgia, 30322
St. Luke's Hospital
Kansas City, Missouri, 64111

Other trials in United States

About this study

Official title: Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure (SMC) System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System in Managing Multiple Venous Access Sites (Evaluation by DUS)

Conditions: Arrhythmia
Being tested: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
Keywords: ABT-CIP-10410, Ablation, DUS, Femoral DUS
Medical subject headings: Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Perclose ProGlide SMC System and/or Perclose ProStyle SMCR SystemDevice
Also called Perclose ProStyle SMCR System
The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.

Study groups in NCT04904809
Study group	Role	What they receive
All Registered Patients	Experimental	All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Receives: Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.
Measured: Within 24 hours of procedure.
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.
Measured: Within 24 hours of procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202127 May 2022

First posted27 May 2021
Study start1 Sep 2021
Primary completion27 May 2022
Study completion27 May 2022

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.
Other trials for ArrhythmiaStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04904809
Sponsor's protocol ID: ABT-CIP-10410
Status last verified: Jul 2023
First submitted: 18 May 2021
Last updated: 20 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure (SMC) System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System in Managing Multiple Venous Access Sites (Evaluation by DUS)
ClinicalTrials.gov ID: NCT04904809
Acronym / sponsor ID: ABT-CIP-10410
Conditions: Arrhythmia
Keywords: ABT-CIP-10410, Ablation, DUS, Femoral DUS
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 1 Sep 2021 (actual)
Primary completion: 27 May 2022 (actual)
Study completion: 27 May 2022 (actual)
First posted: 27 May 2021 (actual)
Results: Posted 20 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Registered Patients	Experimental	Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR SystemAll registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥18 years
Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein
All the access sites are planned to be treated with Perclose SMC
Written informed consent is obtained prior to the procedure

Key exclusion criteria (6 listed)

Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure
Prior ipsilateral deep vein thrombosis within 6 months
International Normalization Ratio >3.5 for patients on warfarin
Subject who is not able to ambulate pre-procedure
Women who are pregnant (based on site standard pre-procedure pregnancy test)

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 SMC System and/or Perclose ProStyle SMCR SystemAlso: Perclose ProStyle SMCR SystemThe Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.	Device	All Registered Patients

Primary outcome

Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
Time frame: Within 24 hours of procedure.
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
Time frame: Within 24 hours of procedure.
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.

Results and safety

Results posted to the registry on 20 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Registered Patients	36	36

Primary outcome: Number of Subjects With Major Vascular Complications by DUS Detection at Discharge

Time frame: Within 24 hours of procedure.. Count of participants. Unit: Participants

Measure	All Registered Patients n = 32
Femoral Vein Stenosis (> 50%) Development at the Puncture	0
Deep Vein Thrombosis in the Target Limb	0
Hematoma	0
Pseudoaneurysm	0
Requiring Surgical or Percutaneous Repair	0
Requiring Thrombin Injection, Fibrin Adhesive Injection, or Ultrasound-guided Compression	0
Arteriovenous (AV) Fistula	0
Venous Tear	0

Population analysed: The number of participants analyzed includes subjects who were available at that time of analysis

Primary outcome: Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge

Time frame: Within 24 hours of procedure.. Count of participants. Unit: Participants

Measure	All Registered Patients n = 32
Femoral Vein Stenosis (> 50%) Development at the Puncture Site related to Closure Techniqu	0
Deep Vein Thrombosis in the Target Limb	3
Hematoma	1
Pseudoaneurysm	0
Arteriovenous (AV) Fistula	0
Venous Tear	0
Venous Perforation	0
Arterial Tear	0

Population analysed: The number of participants analyzed includes subjects who were available at that time of analysis

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Registered Patients	1 of 36 (2.8%)	5 of 36 (13.9%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Arrhythmia

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Enrolling by invitation
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Recruiting
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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.

Sanjaya K Gupta, MD principal investigator

St. Luke's Hospital

Soroosh Kiani, MD principal investigator

Emory University

2 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 SMC System and/or Perclose ProStyle SMCR System in people with Arrhythmia, run by Abbott Medical Devices at 2 sites 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 4 inclusion and 6 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 20 Jul 2023). 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?

Number of Subjects With Major Vascular Complications by DUS Detection at Discharge (time frame: Within 24 hours of procedure.). 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 NCT04904809.

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 20 Jul 2023.