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Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

NCT06871774 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-21

No results posted yet for this study

Summary

This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.

Conditions

  • Transcatheter Aortic Valve Replacement

Interventions

DEVICE

Single Perclose Pro vascular closure device

Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.

DEVICE

Dual Perclose vascular closure device

Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Suhail Q Allaqaband, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2026-06-30
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06871774 on ClinicalTrials.gov