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X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure

This study has been terminated.
(Due to existing evidence eligible patients receive CRT treatment in first place)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157846
First Posted: September 12, 2005
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  Purpose
The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable cardioverter defibrillator (ICD); and have ventricular dysfunction (left ventricular ejection fraction [LVEF] < 35%). All patients eligible for participation in the study will be upgraded with a cardiac resynchronization therapy (CRT)-device and receive either right ventricular or biventricular stimulation in a crossover protocol. The endpoint is functional performance measured by spiroergometry.

Condition Intervention Phase
Heart Failure, Congestive Device: CRT-P or CRT-D Device Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Cardiopulmonary performance measured by spiroergometry [ Time Frame: Baseline to 7 months post-implant ]
    Maximal oxygen uptake (Vo2 max [ml/kg/min])


Secondary Outcome Measures:
  • Left ventricular end diastolic diameter (LVEDD [mm]) [ Time Frame: Baseline to 7 months post-implant ]
  • N-terminal prohormone brain natriuretic peptide (NT-proBNP) [pg/ml] [ Time Frame: Baseline to 7 months post-implant ]
  • Left ventricular ejection fraction (LVEF [%]) [ Time Frame: Baseline to 7 months post-implant ]
  • New York Heart Association (NYHA) Class [ Time Frame: Baseline to 7 months post-implant ]
  • Occurrence of rhythm disturbances: atrial arrhythmias (amount and duration [h/day]) [ Time Frame: Baseline to 7 months post-implant ]
  • Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day]) [ Time Frame: Baseline to 7 months post-implant ]
  • Heart rate variability [ms] [ Time Frame: Baseline to 7 months post implant ]
  • Amount of hospitalizations because of heart failure (amount and duration [days]) [ Time Frame: Baseline to 7 months post-implant ]
  • Cardiopulmonary performance measured by spiroergometry: Oxygen uptake at the anaerobic threshold (VO2 AT [s]) [ Time Frame: Baseline to 7 months post-implant ]
  • Mortality [ Time Frame: Baseline to 7 months post-implant ]

Enrollment: 36
Study Start Date: October 2003
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BiV Pacing
Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months
Device: CRT-P or CRT-D Device
Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)
Active Comparator: RV Stimulation
Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months
Device: CRT-P or CRT-D Device
Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Implanted dual-chamber pacemaker or ICD system with replacement indication

    • Because of battery end of life
    • Because of upgrade from pacemaker to ICD system

      • predominant sinus rhythm (paroxysmal atrial fibrillation [AF] < 2 hours/day)
      • predominant ventricular stimulation (>= 80%)
      • NYHA Class II-III
      • LVEF <= 35%

Exclusion Criteria:

  • NYHA Class IV
  • Life expectancy of less than one year because of accompanying diseases
  • Myocardial infarction less than 3 months old
  • Cardiac surgery less than 3 months

    • Bypass
    • Valve surgery
    • Percutaneous transluminal coronary angioplasty (PTCA)
  • Thoracotomy, for implant of an epicardial LV electrode
  • Medical circumstances that make participation and compliance impossible
  • Patients who are not willing or able to give written consent for their study participation
  • Participation in another study
  • Patients less than 18 years old
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157846


Locations
Germany
Klinikum Augsburg I. Medizinische Klinik
Augsburg, Germany, 86156
Charite Campus Virchow-Klinikum
Berlin, Germany, 13353
Unfallkrankenhaus Benjamin Franklin
Berlin, Germany
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
Bernau, Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany, 44789
Städtisches Kreiskrankenhaus
Friedrichshafen, Germany
Georg-August-Universität Göttingen
Göttingen, Germany
St.-Vincentius Klinken
Karlsruhe, Germany
Märkische Kliniken GmbH Klinikum Luedenscheid
Luedenscheid, Germany, 58515
Krankenhaus Reinbek St. Adolf Stift
Reinbek b. Hamburg, Germany, 21465
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Thomas Lawo, MD Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum
  More Information

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00157846     History of Changes
Other Study ID Numbers: CEN_G_CA_1
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Bakken Research Center:
Heart Failure
LVEF < 35%
Bradycardia

Additional relevant MeSH terms:
Heart Failure
Bradycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes