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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: quadripolar LV lead (Quartet)

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 Type: Observational
• Enrollment (Actual): 337

Contacts and Locations

Study Locations

• Germany
  • Coburg, Germany, 96450
    • Klinikum Coburg GmbH
  • Düsseldorf, Germany, 40472
    • Krankenhaus Mörsenbroich-Rath GmbH
  • Esslingen, Germany, 73730
    • Klinikum Esslingen
  • Frankfurt am Main, Germany, 60389
    • Cardioangiologisches Centrum Bethanien
  • Freiburg, Germany, 79106
    • Universitätsklinik Freiburg
  • Göttingen, Germany, 37073
    • Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Köln, Germany, 51103
    • Evangelisches Krankenhaus Kalk
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Lünen, Germany, 44534
    • St.-Marien-Hospital GmbH
  • Magdeburg, Germany, 39130
    • Klinikum Magdeburg gGmbH
  • Marl, Germany, 45768
    • Marien-Hospital
  • München, Germany, 81377
    • Klinikum Großhadern der Ludwig-Maximilians-Universität München
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Osnabrück, Germany, 49074
    • Niels-Stensen-Kliniken Marienhospital Osnabrück
  • Quedlinburg, Germany, 06484
    • Klinikum Dorothea Christiane Erxleben GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Quadripolar lead; All participants receive a CRT-D system with quadripolar lead	Device: 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 Names: Quartet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold; LV pacing threshold is less or equals 2.5V@0.5ms	Pre hospital discharge (PHD) to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Johannes Brachmann, Prof., Klinikum Coburg GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (ESTIMATE): December 2, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Cardiac resynchronization; CRT-D; Hear Failure; quadripolar
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Ethinyl estradiol, levonorgestrel drug combination
• Other Study ID Numbers: H56