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

Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure, Congestive
• Intervention / Treatment: Device: CRT-P or CRT-D Device

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Medtronic
• Investigators: Principal Investigator: Thomas Lawo, MD, Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 10, 2005
• First Posted (Estimated): September 12, 2005

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; Bradycardia; LVEF < 35%
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Failure; Bradycardia
• Other Study ID Numbers: CEN_G_CA_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO