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Clinical Evaluation Of The PARADYM RF Device

NCT01193634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-06-18

No results posted yet for this study

Summary

The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:

The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture.

Then, the ICD devices have also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.

Finally the study will report the electrical and handling performances of the new left ventricular lead.

Conditions

Interventions

DEVICE

VR 9250 / DR 9550 / CRT 9750

Active implantable defibrillators range

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Sack SS Stefan, Pr · Klinikum Schwabing München Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Germany

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 NCT01193634 on ClinicalTrials.gov