Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads
NCT ID: NCT01484613
Last Updated: 2019-02-04
Study Results
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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COMPLETED
337 participants
OBSERVATIONAL
2011-11-30
2014-06-30
Brief Summary
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Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.
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Detailed Description
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1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
2. LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Quadripolar lead
All participants receive a CRT-D system with quadripolar lead
quadripolar LV lead (Quartet)
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
Interventions
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quadripolar LV lead (Quartet)
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years
* Written informed consent
Exclusion Criteria
* Previous unsuccessful LV lead implant attempt
* Patient is eligible for heart transplantation
* Comorbidities that results in life expectancy of less than 12 months
* Known pregnancy
* Inability to provide written patient informed consent
* Participation to another study with active treatment arm (i.e. randomized studies etc...)
* Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant
* Patient is not able to understand or answer the quality of life questionaire
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Johannes Brachmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
Klinikum Coburg GmbH
Locations
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Klinikum Coburg GmbH
Coburg, , Germany
Evangelisches Krankenhaus Kalk
Cologne, , Germany
Krankenhaus Mörsenbroich-Rath GmbH
Düsseldorf, , Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, , Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, , Germany
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
Göttingen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
St.-Marien-Hospital GmbH
Lünen, , Germany
Klinikum Magdeburg gGmbH
Magdeburg, , Germany
Marien-Hospital
Marl, , Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, , Germany
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, , Germany
Countries
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Other Identifiers
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H56
Identifier Type: -
Identifier Source: org_study_id
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