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

Phase 4

Terminated

• Conditions: Heart Failure, Congestive
• Interventions: Device: CRT-P or CRT-D Device

• Registration Number: NCT00157846
• Lead Sponsor: Medtronic Bakken Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RV Stimulation	CRT-P or CRT-D Device	Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months
BiV Pacing	CRT-P or CRT-D Device	Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
Left ventricular end diastolic diameter (LVEDD [mm])	Baseline to 7 months post-implant
Mortality	Baseline to 7 months post-implant
Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day])	Baseline to 7 months post-implant

Trial Locations

Locations (10)

Städtisches Kreiskrankenhaus; 🇩🇪 Friedrichshafen, Germany

St.-Vincentius Klinken; 🇩🇪 Karlsruhe, Germany

Klinikum Augsburg I. Medizinische Klinik; 🇩🇪 Augsburg, Germany

Charite Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Berufsgenossenschaftliche Kliniken Bergmannsheil; 🇩🇪 Bochum, Germany

Unfallkrankenhaus Benjamin Franklin; 🇩🇪 Berlin, Germany

Georg-August-Universität Göttingen; 🇩🇪 Göttingen, Germany

Märkische Kliniken GmbH Klinikum Luedenscheid; 🇩🇪 Luedenscheid, Germany

Krankenhaus Reinbek St. Adolf Stift; 🇩🇪 Reinbek b. Hamburg, Germany

Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg; 🇩🇪 Bernau, Germany