Heart Failure, Congestive
Conditions
Keywords
Heart Failure, LVEF < 35%, Bradycardia
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.
Interventions
DEVICECRT-P or CRT-D Device
Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary performance measured by spiroergometry | Baseline to 7 months post-implant | Maximal oxygen uptake (Vo2 max \[ml/kg/min\]) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Mortality | Baseline to 7 months post-implant |
| Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day]) | Baseline to 7 months post-implant |
Countries
Germany
Outcome results
None listed