MultipOlar Left Ventricular Electrode Instability Trial

Pacemaker Electrode Lead Displacement Clinical Trial

— MOVE IT  

Official title:

Multipolar Left Ventricular Electrode Instability Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857516
• Other study ID #: GER-EP-022
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2019
• Source: Deutsches Herzzentrum Muenchen
• Contact: Severin Weigand, MD
• Phone: 0049891218
• Email: weigand[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2019
• Est. primary completion date: July 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pacemaker Electrode Lead Displacement

Intervention

Device:
• Multipolar left ventricular lead implantation
Multipolar left ventricular lead implantation with measurements of pacing thresholds in varrious pacing configurations.

Locations

Country	Name	City	State
Germany	Deutsches herzzentrum Muenchen	Muenchen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microdislodgement of leads	Change of pacing threshold	3 months