MultipOlar Left Ventricular Electrode Instability Trial
- Conditions
- Pacemaker Electrode Lead Displacement
- Interventions
- Device: Multipolar left ventricular lead implantation
- 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.
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
- Arm && Interventions
Group Intervention Description Recipients of cardiac resynchronization therapy Multipolar left ventricular lead implantation Consecutive patients with de novo implantation of a cardiac resynchronization defibrillator or pacemaker.
- Primary Outcome Measures
Name Time Method Microdislodgement of leads 3 months Change of pacing threshold
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Deutsches herzzentrum Muenchen
🇩🇪Muenchen, Bavaria, Germany