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

Overview

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.

Full Title of Study: “Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

Interventions

  • 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)

Arms, Groups and Cohorts

  • Experimental: BiV Pacing
    • Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months
  • Active Comparator: RV Stimulation
    • Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Bakken Research Center
  • Collaborator
    • Medtronic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Lawo, MD, Principal Investigator, Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum

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