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Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients

NCT00323661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2012-02-13

No results posted yet for this study

Summary

The purpose of this study is to compare the influence of accelerometer-based rate adaptation and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker patients.

Conditions

  • Cardiac Pacing, Artificial

Interventions

DEVICE

Rate-adaptive pacemaker: accelerometer

Accelerometer based pacing rate adaptation

DEVICE

Rate-adaptive pacemaker: Closed Loop Stimulation

Closed Loop Stimulation (CLS) is a unique concept in rate-adaptive pacing that uses the natural cardiovascular control loop to determine the appropriate pacing rate. Closed Loop Stimulation is the only rate-adaptive system responding to mental stress and thereby assuring optimal cerebral perfusion in everyday activity.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Uwe Wiegand, Prof. Dr. · Sana-Klinikum Remscheid, 42859 Remscheid, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-11-30
Completion
2011-03-31

Countries

  • Australia
  • Austria
  • Brazil
  • Canada
  • Czechia
  • Germany
  • Hong Kong
  • Israel
  • Slovakia
  • Spain

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 NCT00323661 on ClinicalTrials.gov