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

Primary Purpose

Heart Failure, Congestive

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
CRT-P or CRT-D Device
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure, Congestive focused on measuring Heart Failure, LVEF < 35%, Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Augsburg I. Medizinische Klinik
  • Charite Campus Virchow-Klinikum
  • Unfallkrankenhaus Benjamin Franklin
  • Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
  • Berufsgenossenschaftliche Kliniken Bergmannsheil
  • Städtisches Kreiskrankenhaus
  • Georg-August-Universität Göttingen
  • St.-Vincentius Klinken
  • Märkische Kliniken GmbH Klinikum Luedenscheid
  • Krankenhaus Reinbek St. Adolf Stift

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BiV Pacing

RV Stimulation

Arm Description

Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months

Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months

Outcomes

Primary Outcome Measures

Cardiopulmonary performance measured by spiroergometry
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])
Occurrence of rhythm disturbances: 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 spiroergometry: Oxygen uptake at the anaerobic threshold (VO2 AT [s])
Mortality

Full Information

First Posted
September 9, 2005
Last Updated
February 14, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00157846
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to existing evidence eligible patients receive CRT treatment in first place
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Heart Failure, LVEF < 35%, Bradycardia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BiV Pacing
Arm Type
Experimental
Arm Description
Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months
Arm Title
RV Stimulation
Arm Type
Active Comparator
Arm Description
Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months
Intervention Type
Device
Intervention Name(s)
CRT-P or CRT-D Device
Intervention Description
Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)
Primary Outcome Measure Information:
Title
Cardiopulmonary performance measured by spiroergometry
Description
Maximal oxygen uptake (Vo2 max [ml/kg/min])
Time Frame
Baseline to 7 months post-implant
Secondary Outcome Measure Information:
Title
Left ventricular end diastolic diameter (LVEDD [mm])
Time Frame
Baseline to 7 months post-implant
Title
N-terminal prohormone brain natriuretic peptide (NT-proBNP) [pg/ml]
Time Frame
Baseline to 7 months post-implant
Title
Left ventricular ejection fraction (LVEF [%])
Time Frame
Baseline to 7 months post-implant
Title
New York Heart Association (NYHA) Class
Time Frame
Baseline to 7 months post-implant
Title
Occurrence of rhythm disturbances: atrial arrhythmias (amount and duration [h/day])
Time Frame
Baseline to 7 months post-implant
Title
Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day])
Time Frame
Baseline to 7 months post-implant
Title
Heart rate variability [ms]
Time Frame
Baseline to 7 months post implant
Title
Amount of hospitalizations because of heart failure (amount and duration [days])
Time Frame
Baseline to 7 months post-implant
Title
Cardiopulmonary performance measured by spiroergometry: Oxygen uptake at the anaerobic threshold (VO2 AT [s])
Time Frame
Baseline to 7 months post-implant
Title
Mortality
Time Frame
Baseline to 7 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lawo, MD
Organizational Affiliation
Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Augsburg I. Medizinische Klinik
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Charite Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Unfallkrankenhaus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
City
Bernau
Country
Germany
Facility Name
Berufsgenossenschaftliche Kliniken Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Städtisches Kreiskrankenhaus
City
Friedrichshafen
Country
Germany
Facility Name
Georg-August-Universität Göttingen
City
Göttingen
Country
Germany
Facility Name
St.-Vincentius Klinken
City
Karlsruhe
Country
Germany
Facility Name
Märkische Kliniken GmbH Klinikum Luedenscheid
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Krankenhaus Reinbek St. Adolf Stift
City
Reinbek b. Hamburg
ZIP/Postal Code
21465
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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