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FIH Study With CBSO

NCT01960491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-10-11

No results posted yet for this study

Summary

The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).

Conditions

  • Atrial Septal Defect (ASD)
  • Patent Foramen Ovale (PFO)

Interventions

DEVICE

Device Closure of Atrial Septal Defect

Device Closure of Atrial Septal Defect by "Carag Bioresorbable Septal Occluder"

Sponsors & Collaborators

  • Carag AG

    lead INDUSTRY

Principal Investigators

  • Horst Sievert, Prof. Dr. · CardioVaskuläres Centrum Frankfurt, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-01-31
Completion
2018-06-30

Countries

  • Germany

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 NCT01960491 on ClinicalTrials.gov