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:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00157846
First received: September 9, 2005
Last updated: October 8, 2008
Last verified: October 2008
  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 spiroergonometry.


Condition Intervention Phase
Heart Failure, Congestive
Device: Upgrade of old device to CRT-device during exchange
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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 spiroergonometry
  • Maximal oxygen uptake (Vo2 max [ml/kg/min])

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

Estimated Enrollment: 100
Study Start Date: October 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00157846

Locations
Germany
Klinikum Augsburg I. Medizinische Klinik
Augsburg, Germany, 86156
Unfallkrankenhaus Benjamin Franklin
Berlin, Germany
Charite Campus Virchow-Klinikum
Berlin, Germany, 13353
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

No publications provided

ClinicalTrials.gov Identifier: NCT00157846     History of Changes
Other Study ID Numbers: CEN_G_CA_1
Study First Received: September 9, 2005
Last Updated: October 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 22, 2014