Clinical trial NCT01484613: Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads
Official title: Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Hear Failure
Cardiac resynchronization
CRT-D
quadripolar
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are planned for being implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) system in the participating centers.

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.

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 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

Primary outcomes:
measure: Percentage of patients with at least one acceptable lead vector
timeFrame: Pre hospital discharge (PHD) to 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline to 3 months
measure: Phrenic nerve stimulation (PNS)
timeFrame: PHD to 3 months
measure: LV pacing thresholds
timeFrame: PHD to 3 months
measure: Number of acceptable LV lead vectors per patient
timeFrame: PHD to 3 months
measure: Finally programmed LV lead vector
timeFrame: PHD to 3 months
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Düsseldorf
country: Germany
facility: Krankenhaus Mörsenbroich-Rath GmbH
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Frankfurt am Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
city: Göttingen
country: Germany
facility: Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gGmbH
city: Marl
country: Germany
facility: Marien-Hospital
city: München
country: Germany
facility: Klinikum Großhadern der Ludwig-Maximilians-Universität München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Marienhospital Osnabrück
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben GmbH
Study officials:
affiliation: Klinikum Coburg GmbH
name: Johannes Brachmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References: