Right Apical Versus Septal Pacing Trial
- Conditions
- Heart BlockHeart Failure
- Interventions
- Device: Septal RV lead placementDevice: Apical RV lead placement
- Registration Number
- NCT00199498
- Lead Sponsor
- Lawson Health Research Institute
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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
- the subject is 18 years of age or older
- the subject has provided written consent -
- Pre-existing permanent cardiac pacemaker or ICD (defibrillator)
- Presence of Hypertrophic Obstructive Cardiomyopathy
- Recent cardiac surgery (</= 30 days)
- Recent myocardial infarction (</= 30 days)
- Presence of mechanical prosthetic tricuspid valve
- Patient inability or unwillingness to comply with study protocol and required study visit schedule
- Concomitant research study whose protocol would conflict or affect the outcome of this study
- Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Septal RV lead placement Septal RV lead placement patient randomized to Septal RV lead placement Apical RV lead placement Apical RV lead placement patient randomized to Apical RV lead placement (current standard placement)
- Primary Outcome Measures
Name Time Method LV ejection fraction measured by radionuclide ventriculography (RVG). 2 weeks, 24 months and 36 months
- Secondary Outcome Measures
Name Time Method All cause mortality. 36 months total implant procedure and fluoroscopy time Implant Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation. 36 months Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores. 2 weeks, 24 and 36 months Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP). 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 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
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada