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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01484613
First received: November 30, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Heart Failure
Device: quadripolar LV lead (Quartet)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percentage of patients with at least one acceptable lead vector [ Time Frame: Pre hospital discharge (PHD) to 3 months ] [ Designated as safety issue: No ]

    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:
  • Quality of Life [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    Minnesota living with heart failure questionaire

  • Phrenic nerve stimulation (PNS) [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
    • Incidence of PNS per LV pacing vector
    • Freedom from PNS for the permanently programmed LV vector

  • LV pacing thresholds [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
    • LV pacing thresholds per LV vector
    • Incidence of elevated (>2.5V/0.5ms) LV pacing thresholds per LV vector

  • Number of acceptable LV lead vectors per patient [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
  • Finally programmed LV lead vector [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
    • Need for reprogramming
    • Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors


Estimated Enrollment: 337
Study Start Date: November 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Quadripolar lead
All participants receive a CRTD 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 Name: 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 2.5V@0.5ms
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are planned for being implanted with a CRT-D system in the participating centers.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484613

Contacts
Contact: Johannes Brachmann, Prof. +49 9561-22-6348 johannes.brachmann@klinikum-coburg.de

Locations
Germany
Klinikum Coburg GmbH Recruiting
Coburg, Germany, 96450
Contact: Johannes Brachmann, Prof.         
Principal Investigator: Johannes Brachmann, Prof.         
Krankenhaus Mörsenbroich-Rath GmbH Recruiting
Düsseldorf, Germany, 40472
Contact: Bernfried Schulte-Pitzke, Dr.         
Principal Investigator: Bernfried Schulte-Pitzke, Dr.         
Klinikum Esslingen Recruiting
Esslingen, Germany, 73730
Contact: Armin Wöhrle, Dr.         
Sub-Investigator: Christoph Bollinger, Dr. med.         
Principal Investigator: Armin Wöhrle, Dr.         
Cardioangiologisches Centrum Bethanien Recruiting
Frankfurt am Main, Germany, 60389
Contact: Oliver Przibille, Dr.         
Principal Investigator: Oliver Przibille, Dr.         
Universitätsklinik Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Stefan Asbach, Dr.         
Principal Investigator: Stefan Asbach, Dr.         
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem Recruiting
Göttingen, Germany, 37073
Contact: Claudius Hansen, Dr.         
Principal Investigator: Claudius Hansen, Dr.         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Hanno Oswald, PD Dr. med.         
Principal Investigator: Hanno Oswald, PD Dr. med.         
Evangelisches Krankenhaus Kalk Recruiting
Köln, Germany, 51103
Contact: Frank Eberhardt, Dr. med.         
Principal Investigator: Frank Eberhardt, Dr. med.         
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Recruiting
Ludwigshafen, Germany, 67063
Contact: Ralf Zahn, PD Dr. med.    +49-621-503-4000      
Principal Investigator: Ralf Zahn, PD Dr. med.         
St.-Marien-Hospital GmbH Recruiting
Lünen, Germany, 44534
Contact: Christian Perings, Prof. Dr.         
Principal Investigator: Christian Perings, Prof. Dr.         
Klinikum Magdeburg gGmbH Recruiting
Magdeburg, Germany, 39130
Contact: Hendrik Schmidt, PD Dr.         
Principal Investigator: Hendrik Schmidt, PD Dr.         
Marien-Hospital Recruiting
Marl, Germany, 45768
Contact: Michael Markant, Dr.         
Principal Investigator: Michael Markant, Dr.         
Klinikum Großhadern der Ludwig-Maximilians-Universität München Recruiting
München, Germany, 81377
Contact: Stefan Kääb, PD Dr. med.         
Principal Investigator: Stefan Kääb, PD Dr. med.         
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Lars Eckardt, Prof. Dr.         
Principal Investigator: Lars Eckardt, Prof. Dr.         
Niels-Stensen-Kliniken Marienhospital Osnabrück Recruiting
Osnabrück, Germany, 49074
Contact: Heinrich Weglage, Dr.         
Principal Investigator: Heinrich Weglage, Dr.         
Klinikum Dorothea Christiane Erxleben GmbH Recruiting
Quedlinburg, Germany, 06484
Contact: Sven Fischer, Dr. med.         
Principal Investigator: Sven Fischer, Dr.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Johannes Brachmann, Prof. Klinikum Coburg GmbH
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01484613     History of Changes
Other Study ID Numbers: H56
Study First Received: November 30, 2011
Last Updated: July 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
Hear Failure
Cardiac resynchronization
CRTD
quadripolar

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014