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Ingenio Device Algorithm Study

NCT01441583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2024-03-21

Study results available
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Summary

The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

Conditions

Interventions

DEVICE

RAAT

For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)

DEVICE

RYTHMIQ

For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Roy S Gardner, MD · Golden Jubilee National Hospital

  • Jens Goetzke, Dipl.-Ing. (FH) · Boston Scientific Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-06-30
Completion
2013-04-30

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Italy
  • Malaysia
  • Netherlands
  • Spain
  • Sweden
  • 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 NCT01441583 on ClinicalTrials.gov