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This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement

NCT06983938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-03-16

Study results available
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Summary

This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.

Conditions

  • Transcatheter Aortic Valve Replacement
  • Closure Technique

Interventions

DEVICE

Double Perclose Proglide

Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.

DEVICE

Single Perclose Proglide plus Angioseal

Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-12
Primary Completion
2025-08-13
Completion
2025-10-15
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 NCT06983938 on ClinicalTrials.gov