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 )

First Received: September 9, 2005 Last Updated: October 8, 2008 History of Changes

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00157846

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 IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157846

Locations

Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany, 44789
Charite Campus Virchow-Klinikum
Berlin, Germany, 13353
Klinikum Augsburg I. Medizinische Klinik
Augsburg, Germany, 86156
Märkische Kliniken GmbH Klinikum Luedenscheid
Luedenscheid, Germany, 58515
Krankenhaus Reinbek St. Adolf Stift
Reinbek b. Hamburg, Germany, 21465
St.-Vincentius Klinken
Karlsruhe, Germany
Städtisches Kreiskrankenhaus
Friedrichshafen, Germany
Unfallkrankenhaus Benjamin Franklin
Berlin, Germany
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
Bernau, Germany
Georg-August-Universität Göttingen
Göttingen, Germany

Sponsors and Collaborators

Medtronic Bakken Research Center

Medtronic

Investigators

Principal Investigator:

Thomas Lawo, MD

Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum

More Information

No publications provided

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

Keywords provided by Medtronic Bakken Research Center:

Heart Failure
LVEF < 35%
Bradycardia

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Bradycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Failure
Pathologic Processes
Heart Diseases

Bradycardia
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009