MedTrace Logo

Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)

NCT02488239 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2019-09-20

Study results available
· View outcomes & findings →

Summary

The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P devices (CRT-Ps), both in general and specific to the new features and hardware of the devices.

Conditions

  • Post Market Surveillance Study Following Clinical Routine

Interventions

DEVICE

CRT-P indicated patients

Patients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • S. Pakarinen, Dr. · Helsinki University Central Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Finland
  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT02488239 on ClinicalTrials.gov