Clinical trial NCT00157846: X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure
Official title: Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Keywords: Heart Failure
LVEF < 35%
Bradycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Cardiopulmonary performance measured by spiroergometry
timeFrame: Baseline to 7 months post-implant
Secondary outcomes:
measure: Left ventricular end diastolic diameter (LVEDD [mm])
timeFrame: Baseline to 7 months post-implant
measure: N-terminal prohormone brain natriuretic peptide (NT-proBNP) [pg/ml]
timeFrame: Baseline to 7 months post-implant
measure: Left ventricular ejection fraction (LVEF [%])
timeFrame: Baseline to 7 months post-implant
measure: New York Heart Association (NYHA) Class
timeFrame: Baseline to 7 months post-implant
measure: Occurrence of rhythm disturbances: atrial arrhythmias (amount and duration [h/day])
timeFrame: Baseline to 7 months post-implant
measure: Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day])
timeFrame: Baseline to 7 months post-implant
measure: Heart rate variability [ms]
timeFrame: Baseline to 7 months post implant
measure: Amount of hospitalizations because of heart failure (amount and duration [days])
timeFrame: Baseline to 7 months post-implant
measure: Cardiopulmonary performance measured by spiroergometry: Oxygen uptake at the anaerobic threshold (VO2 AT [s])
timeFrame: Baseline to 7 months post-implant
measure: Mortality
timeFrame: Baseline to 7 months post-implant
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg I. Medizinische Klinik
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: Unfallkrankenhaus Benjamin Franklin
city: Bernau
country: Germany
facility: Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannsheil
city: Friedrichshafen
country: Germany
facility: Städtisches Kreiskrankenhaus
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen
city: Karlsruhe
country: Germany
facility: St.-Vincentius Klinken
city: Luedenscheid
country: Germany
facility: Märkische Kliniken GmbH Klinikum Luedenscheid
city: Reinbek b. Hamburg
country: Germany
facility: Krankenhaus Reinbek St. Adolf Stift
Study officials:
affiliation: Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum
name: Thomas Lawo, MD
role: PRINCIPAL_INVESTIGATOR
References: