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AMBULATE Same Day Discharge Registry

NCT04203329 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2022-08-10

No results posted yet for this study

Summary

A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.

Conditions

  • Vascular Closure

Interventions

DEVICE

Femoral Venous Vascular Closure

Femoral venous vascular closure following catheter-based cardiac ablation a-fib cases utilizing 6-12 French inner diameter procedural sheaths at time of closure.

Sponsors & Collaborators

  • Cardiva Medical, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2023-12-31
Completion
2023-12-31
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 NCT04203329 on ClinicalTrials.gov