CompletedNot Applicable

Perclose Multi-Access Duplex Ultrasound (DUS) Study

United States36 participantsStarted 2021-09-01

Plain-language 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 non-visible subjects.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

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

Timeframe: Within 24 hours of procedure.

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

Timeframe: Within 24 hours of procedure.

Trial details

NCT IDNCT04904809

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-27

Results submitted2023-05-26

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