Heart Block, Heart Failure
Conditions
Keywords
Permanent Pacemaker Implantation- Lead Position
Brief summary
The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing.
Detailed description
The primary objective of this study is to compare the effect of RV pacing site on LV systolic function as measured by LVEF (left ventricular ejection fraction). Secondary objectives of this trial include: 1. to compare the effect of RVSeptal(RVS) versus RVApical(RVA)pacing on other indices of systolic and diastolic LV function 2. to compare the rate of heart failure-related hospitalization between RVS versus RVA pacing 3. to compare new-onset atrial fibrillation and stroke rates between RVS versus RVA pacing 4. to assess the effect of RVA versus RVS pacing on quality of life and functional capacity 5. to compare the rate of successful pacemaker lead implantation, complications and chronic electrical performance of RVS versus RVA pacing
Interventions
DEVICEApical RV lead placement
RV lead implanted ( according to randomization )at the apex
DEVICESeptal RV lead placement
RV lead is implanted (according to randomization), on septum
Sponsors
Medtronic
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. a)Fixed (third degree) AV block b) Atrial Fibrillation with average Ventricular rate on ECG \</= 40bpm or mean heart rate on Holter monitor \</= 60bpm c) Sinus node Dysfunction with PR interval \>/= 300msec d) Paroxysmal, persistent or permanent AF undergoing AV node , AV node/HIS ablation e) 2°AV Block with ≥3:1 block 2. the subject is 18 years of age or older 3. the subject has provided written consent -
Exclusion criteria
1. Pre-existing permanent cardiac pacemaker or ICD (defibrillator) 2. Presence of Hypertrophic Obstructive Cardiomyopathy 3. Recent cardiac surgery (\</= 30 days) 4. Recent myocardial infarction (\</= 30 days) 5. Presence of mechanical prosthetic tricuspid valve 6. Patient inability or unwillingness to comply with study protocol and required study visit schedule 7. Concomitant research study whose protocol would conflict or affect the outcome of this study 8. Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LV ejection fraction measured by radionuclide ventriculography (RVG). | 2 weeks, 24 months and 36 months |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality. | 36 months |
| Non-fatal thromboembolic events including stroke. | 36 months |
| Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic. | 36 months |
| Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation. | 36 months |
| Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP). | 36 months |
| NYHA class using SAS survey, 6 minute hall walk distance. | 2 weeks, 24 and 36 months |
| lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold | 2 weeks, 24 and 36 months |
| total implant procedure and fluoroscopy time | Implant |
| Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores. | 2 weeks, 24 and 36 months |
Countries
Canada
Outcome results
None listed