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Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads

Information source: St. Jude Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: quadripolar LV lead (Quartet) (Device)

Phase: N/A

Status: Completed

Sponsored by: St. Jude Medical

Official(s) and/or principal investigator(s):
Johannes Brachmann, Prof., Principal Investigator, Affiliation: Klinikum Coburg GmbH

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.

Clinical Details

Official title: Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Percentage of patients with at least one acceptable lead vector

Secondary outcome:

Quality of Life

Phrenic nerve stimulation (PNS)

LV pacing thresholds

Number of acceptable LV lead vectors per patient

Finally programmed LV lead vector

Detailed description: Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) 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. 5Volts (V) @0. 5 milliseconds (ms)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Indication for implantation of a CRT-D

- Age >= 18 years

- Written informed consent

Exclusion Criteria:

- 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

Locations and Contacts

Klinikum Coburg GmbH, Coburg 96450, Germany

Krankenhaus Mörsenbroich-Rath GmbH, Düsseldorf 40472, Germany

Klinikum Esslingen, Esslingen 73730, Germany

Cardioangiologisches Centrum Bethanien, Frankfurt am Main 60389, Germany

Universitätsklinik Freiburg, Freiburg 79106, Germany

Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem, Göttingen 37073, Germany

Medizinische Hochschule Hannover, Hannover 30625, Germany

Evangelisches Krankenhaus Kalk, Köln 51103, 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

Additional Information

Starting date: November 2011
Last updated: November 21, 2014

Page last updated: August 23, 2015

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