MultipOlar Left Ventricular Electrode Instability Trial

• Conditions: Pacemaker Electrode Lead Displacement

• Registration Number: NCT03857516
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

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

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 Timeline

• Study Start: 2018-10-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Study First Posted: 2019-02-28
• Last Update Posted: 2019-02-28
• Primary Completion: 2019-07-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microdislodgement of leads	3 months	Change of pacing threshold

Trial Locations

Locations (1)

Deutsches herzzentrum Muenchen; 🇩🇪 Muenchen, Bavaria, Germany