MultipOlar Left Ventricular Electrode Instability Trial (MOVE IT)

Multipolar Left Ventricular Electrode Instability Trial

Characterization of pacing thresholds in available pacing vectors of quadripolar leads used for cardiac resynchronization therapy in a short term follow-up.

Study Overview

• Status: Unknown
• Conditions: Pacemaker Electrode Lead Displacement
• Intervention / Treatment: Device: Multipolar left ventricular lead implantation

Detailed Description

Multipolar left ventricular leads are increasingly used in cardiac resynchronization therapy. Lead dislodgment requiring re-intervention is rare. However, data on minor lead movements which may affect pacing capabilities and application of new pacing algorithms is scarce. Aim of the study is to characterize pacing thresholds of each of the implanted electrodes on quadripolar leads in a short term follow-up.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Muenchen, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum Muenchen
      • Contact: Severin Weigand, MD; Phone Number: 2020 0049891218; Email: weigand@dhm.mhn.de
      • Contact: Christof Kolb, MD; Phone Number: 2020 0049891218; Email: kolb@dhm.mhn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving cardiac resynchronization therapy according to guidelines with the implantation of a multipolar left ventricular lead.

Description

Inclusion Criteria:

• De novo implantation of left ventricular multipolar leads.

Exclusion Criteria:

• Cardiogenic shock
• Device infection
• Revision for previously dislodged left ventricular lead
• Age below 18 years
• Pregnancy
• Patients under tutelage

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Recipients of cardiac resynchronization therapy; Consecutive patients with de novo implantation of a cardiac resynchronization defibrillator or pacemaker.	Device: Multipolar left ventricular lead implantation; Multipolar left ventricular lead implantation with measurements of pacing thresholds in varrious pacing configurations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microdislodgement of leads	Change of pacing threshold	3 months

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Study Chair: Christof Kolb, MD, Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: GER-EP-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No