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

Study Overview
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Brief Summary
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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.

Official Title
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Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: CRT-P or CRT-D Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiV Pacing<br>Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months | Device: CRT-P or CRT-D Device<br>* Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)<br>|
| Active Comparator: RV Stimulation<br>Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months | Device: CRT-P or CRT-D Device<br>* Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary performance measured by spiroergometry | Maximal oxygen uptake (Vo2 max [ml/kg/min]) | Baseline to 7 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular end diastolic diameter (LVEDD [mm]) |  | 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 | 
| Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day]) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, LVEF < 35%, Bradycardia