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

Completed

• Conditions: Heart Failure
• Interventions: Device: quadripolar LV lead (Quartet)

• Registration Number: NCT01484613
• Lead Sponsor: Abbott Medical Devices

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)

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Quadripolar lead	quadripolar LV lead (Quartet)	All participants receive a CRT-D system with quadripolar lead

Primary Outcome Measures

Name	Time	Method
Percentage of patients with at least one acceptable lead vector	Pre hospital discharge (PHD) to 3 months	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

Secondary Outcome Measures

Name	Time	Method
LV pacing thresholds	PHD to 3 months	* LV pacing thresholds per LV vector; * Incidence of elevated (\>2.5V/0.5ms) LV pacing thresholds per LV vector
Quality of Life	Baseline to 3 months	Minnesota living with heart failure questionaire
Phrenic nerve stimulation (PNS)	PHD to 3 months	* Incidence of PNS per LV pacing vector; * Freedom from PNS for the permanently programmed LV vector
Number of acceptable LV lead vectors per patient	PHD to 3 months
Finally programmed LV lead vector	PHD to 3 months	* Need for reprogramming; * Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors

Trial Locations

Locations (16)

Klinikum Coburg GmbH; 🇩🇪 Coburg, Germany

Krankenhaus Mörsenbroich-Rath GmbH; 🇩🇪 Düsseldorf, Germany

Klinikum Esslingen; 🇩🇪 Esslingen, Germany

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt am Main, Germany

Universitätsklinik Freiburg; 🇩🇪 Freiburg, Germany

Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem; 🇩🇪 Göttingen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, 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

Evangelisches Krankenhaus Kalk; 🇩🇪 Köln, Germany