Pacing-Induced Cardiomyopathy
Conditions
Keywords
His bundle pacing, Right ventricular pacing, Left ventricular systolic function
Brief summary
This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)\>40%. The primary outcome measure is LVEF.
Detailed description
Monocentric, randomized, double-blind comparative crossover clinical study. Patients with a standard pacing indication with \>20% ventricular pacing, with a baseline LVEF \>40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.
Interventions
DEVICEHis bundle pacing
Pacing with capture of the His bundle
DEVICERight ventricular pacing
Pacing from the right ventricular lead (septal or apical)
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized crossover double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Baseline LVEF\>40% * Standard pacing indication with \>20% VP * Functional His bundle lead with confirmed His capture * Functional right ventricular lead with myocardial capture
Exclusion criteria
* Unable to sign an informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction | 6 months | Assessed by gated Equilibrium Radionuclide Angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NYHA functional class | 6 months | Investigator evaluation |
| 6-minute walk test | 6 months | Investigator evaluation |
| Left ventricular peak filling rate (EDV/s) | 6 months | Assessed by gated Equilibrium Radionuclide Angiography |
| Right ventricular ejection fraction | 6 months | Assessed by gated Equilibrium Radionuclide Angiography |
| Hospital admission for cardiovascular causes | 6 months | Number of days of admissions for cardiovascular causes |
| Quality of life measure by SF-36 questionnaire | 6 months | SF-36 questionnaire; 0-100 score (the higher the score, the better the quality of life) |
Countries
Switzerland
Outcome results
None listed