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INGEVITY™ Observational Trial

NCT02166606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1184

Last updated 2021-03-30

Study results available
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Summary

The objectives of this registry are to

1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events
2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts.
3. Collect physician feedback on lead handling with the INGEVITY lead

in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.

Conditions

  • Bradycardia

Interventions

DEVICE

ImageReady MR Conditional Pacing System Implant

Implant according to standard-of-care. No study-specific interventions in that registry.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Daniel Gras, MD · Nouvelles Cliniques Nantaises Cardiologie / Médecins du pôle - Unité de Soins et de Cardiologie Interventionnelle 4 rue Eric Tabarly 44277 Nantes cedex 2 France

  • John doe, MD

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-06-30
Completion
2016-09-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Norway
  • Portugal
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT02166606 on ClinicalTrials.gov