A Comparison Between Right Ventricular Apical Pacing and True Mid-septal Pacing, Verified With Computed Tomography: a Randomized Study
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change from baseline in the left ventricular ejection fraction at 6 months
Study Overview
Brief Summary
Background Right ventricular (RV) artificial apical pacing can negatively impact synchrony of left ventricular contraction. The pacing from the septum of the RV can present an advantage in terms of less expressed dyssynchrony and reduced negative impact on left ventricular (LV) function. However, results of randomized studies comparing apical and septal pacing are not uniform. All these results have been affected by improper implantation of the septal lead, with many apparently septal leads being, in fact, implanted off-septum. The aim of the study is to compare true septal pacing with other RV pacing locations.
Methods/Design This is a prospective, randomized, single center study. Patients with standard indications for cardiac pacing with the expectation of high percentage RV pacing will be enrolled. They will be randomized into apical and septal pacing. The real location of leads in patients randomized to septal pacing will be confirmed using cardiac CT. After cardiac CT, three groups of patients will be created: 1) apical pacing, 2) true septal (in which the position of the lead has been verified to be in the septum), and 3) apparent septal (in which the position of the lead was found to be off-septum). Primary end-point are changes in standard echocardiographic parameters (LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume) and the concentration of N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to 6 months, 1 year and three years. Secondary end-points are changes in echo-parameters of LV synchrony.
Discussion It is hypothesized that correct septal pacing will be associated with reduce negative impact on the function of the left ventricle (i.e. smaller decreases in LV EF and smaller increases in LVEDV, LVESV) and NT-proBNP, and less expressed LV dyssynchrony.
Detailed Description
METHODS/DESIGN The study is planned as prospective, multicenter, randomized study. The study was approved by the local ethics committee, and written informed consent will be obtained before enrollment of patients.
Inclusion criteria will be the following:
- Indication for cardiac pacing based on recent guidelines of European Society of Cardiology (5)
- High degree atrio-ventricular (AV) block (AV block 2/1 or second degree AV block with resulting heart rate below 50), or atrial fibrillation with slow conduction to ventricles.
- A high probability of needing significant ventricular stimulation (more than 50%)
- Written informed consent.
Exclusion criteria will be the following:
- The absence of written informed consent
- Renal insufficiency (creatinine level more than 130 µmol/l)
- History of Iodine allergy
- Claustrophobia
- Significant valve disease (i.e. mitral insufficiency 75% and worse, moderate or severe aortic stenosis)
- Recent (within three months) acute coronary syndrome
- Planned cardiac surgery (coronary artery bypass grafting, valve surgery)
- Ejection fraction of left ventricle less than 50%
- Expected life expectancy less than 3 years
- Expected non-compliance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
RV lead in the septum
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Indication for cardiac pacing.
Exclusion Criteria
- •renal insufficiency
- •iod allergy
- •claustrophobia
- •significant valvular disease
- •recent acute coronary syndrome
- •planned cardiac surgery
- •ejection fraction of left ventricle less than 50%
- •live expectancy less than 3 years
- •expected non-compliance of the patient
Outcomes
Primary Outcomes
Change from baseline in the left ventricular ejection fraction at 6 months
Time Frame: from baseline to 6 months
The changes over time in the left ventricular ejection fraction will be determined.
Change from baseline in the left ventricular end-systolic volume at 6 months
Time Frame: from baseline to 6 months
The changes over time in the left ventricular end-systolic volume will be determined.
Change from baseline in the left ventricular end-systolic volume at 3 years.
Time Frame: from baseline to 3 years
The changes over time in the left ventricular ejection fraction will be determined.
Change from baseline in the concentration of N-terminal pro-Brain Natriuretic Peptide at 6 months
Time Frame: from baseline to 6 months
The changes over time in the concentration of the N-terminal pro-brain natriuretic peptide will be determined.
Change from baseline in the left ventricular ejection fraction at 3 years
Time Frame: from baseline to 3 years
The changes over time in the left ventricular ejection fraction will be determined.
Change from baseline in the concentration of N-terminal pro-Brain Natriuretic Peptide at 3 years.
Time Frame: from baseline to 3 years
The changes over time in the concentration of the N-terminal pro-brain natriuretic peptide will be determined.
Secondary Outcomes
- Change from baseline in dyssynchrony at 6 months(from baseline to 6 months)
- Change from baseline in dyssynchrony at 3 years.(from baseline to 3 years)
- Change from baseline in the left ventricular end-diastolic volume at 6 months(from baseline to 6 months)
- Change from baseline in the left ventricular end-diastolic volume at 3 years.(from baseline to 3 years)
Investigators
Pavel Osmancik
Charles University in Prague, Czech Republic
Charles University, Czech Republic