Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead (MSLV)

January 31, 2019 updated by: Abbott Medical Devices
The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.

Study Overview

Status

Completed

Conditions

Detailed Description

To evaluate the hemodynamic impact of different pacing MSLV configurations.

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany
        • Herzzentrum
      • Bad Nauheim, Germany
        • Kerckhoff - Klinik
      • Bad Oeynhausen, Germany
        • Herz-und Diabetes Zentrum NRW
      • Bad Rothenfelde, Germany
        • Schuchtermannklinik
      • Frankfurt, Germany
        • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
      • Ludwigshafen, Germany
        • Städt. Klinikum
      • Rosenheim, Germany
        • Klinikum Rosenheim
  • United Kingdom
      • Dudley, United Kingdom
        • Russells Hall
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital
      • London, United Kingdom
        • St Thomas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with standard CRT-D indications

Description

Inclusion Criteria:

  • Patients who have a recognised indication to receive a CRT-D device or an upgrade from a pacemaker or ICD to a CRT-D system.
  • Patients have signed an informed consent form indicating their willingness to participate to this study.

Exclusion Criteria:

  • Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
  • Patients with second or third degree AV Block
  • Patients with intrinsic atrial rhythm < 40 bpm
  • Patients with a previously implanted left ventricular pacing lead.
  • Patients who are pregnant.
  • Patients currently participating in a clinical investigation that includes an active treatment arm.
  • Patients under 18 years of age.
  • Patients with a life expectancy of less then 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR-09-048-EU-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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