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Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF

NCT02521896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-08-13

No results posted yet for this study

Summary

The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation and persistent atrial fibrillation (AF). The study will be a prospective, single-center, non-randomized investigation.

Conditions

Interventions

DEVICE

Steerable Sheath System

The Vado™ Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible catheter positioning in the cardiac anatomy.

Sponsors & Collaborators

  • Kalila Medical

    lead INDUSTRY

Principal Investigators

  • Ian Crozier, MD · Christchurch Hospital

  • Matthew Daly, MD · Christchurch Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2015-01-31

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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 NCT02521896 on ClinicalTrials.gov