Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads
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Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads
1 other identifier
observational
337
1 country
16
Brief Summary
Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 4, 2019
February 1, 2019
2.6 years
November 30, 2011
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with at least one acceptable lead vector
Definition of acceptable lead vector: Any LV vector that complies in both tested body positions with both criteria: 1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold 2. LV pacing threshold is less or equals 2.5V@0.5ms
Pre hospital discharge (PHD) to 3 months
Secondary Outcomes (5)
Quality of Life
Baseline to 3 months
Phrenic nerve stimulation (PNS)
PHD to 3 months
LV pacing thresholds
PHD to 3 months
Number of acceptable LV lead vectors per patient
PHD to 3 months
Finally programmed LV lead vector
PHD to 3 months
Study Arms (1)
Quadripolar lead
All participants receive a CRT-D system with quadripolar lead
Interventions
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
Eligibility Criteria
Patients who are planned for being implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) system in the participating centers.
You may qualify if:
- Indication for implantation of a CRT-D
- Age \>= 18 years
- Written informed consent
You may not qualify if:
- Already implanted LV or coronary sinus lead
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Klinikum Coburg GmbH
Coburg, 96450, Germany
Evangelisches Krankenhaus Kalk
Cologne, 51103, Germany
Krankenhaus Mörsenbroich-Rath GmbH
Düsseldorf, 40472, Germany
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60389, Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
Göttingen, 37073, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063, Germany
St.-Marien-Hospital GmbH
Lünen, 44534, Germany
Klinikum Magdeburg gGmbH
Magdeburg, 39130, Germany
Marien-Hospital
Marl, 45768, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, 81377, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, 49074, Germany
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, 06484, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johannes Brachmann, Prof.
Klinikum Coburg GmbH
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 2, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
February 4, 2019
Record last verified: 2019-02