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Safety and Performance Study of the INGEVITY Lead

NCT01688843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1060

Last updated 2020-03-10

Study results available
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Summary

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

Conditions

  • Bradycardia
  • Sinus Node Dysfunction

Interventions

DEVICE

INGEVITY lead

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Charles Love, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-01-31
Completion
2019-02-28
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Italy
  • Malaysia
  • Portugal
  • Spain
  • Sweden
  • Thailand
  • 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 NCT01688843 on ClinicalTrials.gov