Status:
TERMINATED
X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 pac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00157846
Start Date
October 1 2003
End Date
August 1 2008
Last Update
July 3 2025
Active Locations (10)
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1
Klinikum Augsburg I. Medizinische Klinik
Augsburg, Germany, 86156
2
Charite Campus Virchow-Klinikum
Berlin, Germany, 13353
3
Unfallkrankenhaus Benjamin Franklin
Berlin, Germany
4
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
Bernau, Germany