MedTrace Logo

Safety and Clinical Performance of the Protecta ICD and CRT-D

NCT00982397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2770

Last updated 2017-11-06

Study results available
· View outcomes & findings →

Summary

The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.

Conditions

Interventions

DEVICE

Protecta VR-ICD

Protecta single-chamber implantable cardioverter defibrillators.

DEVICE

Protecta DR-ICD or CRT-D

Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • A. Meijer, Dr. · Eindhoven, The Netherlands

  • A. Auricchio, Prof. · Lugano, Switzerland

  • T. Kurita, Dr. · Higashi-Osaka, Japan

  • E.J. Schloss, Dr. · Cincinnati Ohio, USA

  • L. Sterns, Dr. · Victoria, British Columbia, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States
  • Austria
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Saudi Arabia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

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 NCT00982397 on ClinicalTrials.gov