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MultipOlar Left Ventricular Electrode Instability Trial

NCT ID: NCT03857516

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pacemaker Electrode Lead Displacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recipients of cardiac resynchronization therapy

Consecutive patients with de novo implantation of a cardiac resynchronization defibrillator or pacemaker.

Multipolar left ventricular lead implantation

Intervention Type DEVICE

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

Interventions

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Multipolar left ventricular lead implantation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christof Kolb, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches herzzentrum Muenchen

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Severin Weigand, MD

Role: CONTACT

Phone: 0049891218

Email: [email protected]

Christof Kolb, MD

Role: CONTACT

Phone: 0049891218

Email: [email protected]

Facility Contacts

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Severin Weigand, MD

Role: primary

Christof Kolb, MD

Role: backup

Other Identifiers

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GER-EP-022

Identifier Type: -

Identifier Source: org_study_id