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More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges

NCT01510652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1078

Last updated 2019-02-15

Study results available
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Summary

This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.

Conditions

  • Postoperative Cardiac Complication
  • Heart Failure
  • Left Ventricular Cardiac Dysfunction
  • Inappropriate Phrenic Nerve Stimulation
  • Perioperative/Postoperative Complications

Interventions

PROCEDURE

BiP Group

Implantation of standard Left Ventricular (LV) lead

DEVICE

Quad Group

Implantation of quadripolar Left ventricular (LV) lead Quartet

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Giuseppe Boriani, Pro. · Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Belgium
  • Canada
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • 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 NCT01510652 on ClinicalTrials.gov