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Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation

NCT05563142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-07-01

No results posted yet for this study

Summary

Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).

Conditions

Interventions

PROCEDURE

deploying vascular closure device versus manual compression

patients will be randomized to either group 1 or group 2 in a 1:1 ratio:

Sponsors & Collaborators

  • University of Luebeck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT05563142 on ClinicalTrials.gov