Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 36
- Locations
- 18
- Primary Endpoint
- Cardiopulmonary performance measured by spiroergometry
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
BiV Pacing
Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months
Intervention: CRT-P or CRT-D Device (Device)
RV Stimulation
Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months
Intervention: CRT-P or CRT-D Device (Device)
Outcomes
Primary Outcomes
Cardiopulmonary performance measured by spiroergometry
Time Frame: Baseline to 7 months post-implant
Maximal oxygen uptake (Vo2 max \[ml/kg/min\])
Secondary Outcomes
- 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)