Right Apical Versus Septal Pacing Trial

Study Overview
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Brief Summary
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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
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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: to compare the effect of RVSeptal(RVS) versus RVApical(RVA)pacing on other indices of systolic and diastolic LV function to compare the rate of heart failure-related hospitalization between RVS versus RVA pacing to compare new-onset atrial fibrillation and stroke rates between RVS versus RVA pacing to assess the effect of RVA versus RVS pacing on quality of life and functional capacity to compare the rate of successful pacemaker lead implantation, complications and chronic electrical performance of RVS versus RVA pacing

Official Title
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Right Apical Versus Septal Pacing Trial

Conditions
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Heart Block, Heart Failure

Intervention / Treatment
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* Device: Apical RV lead placement
* Device: Septal RV lead placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 - Exclusion Criteria: 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

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septal RV lead placement<br>patient randomized to Septal RV lead placement | Device: Septal RV lead placement<br>* RV lead is implanted (according to randomization), on septum<br>|
| Active Comparator: Apical RV lead placement<br>patient randomized to Apical RV lead placement (current standard placement) | Device: Apical RV lead placement<br>* RV lead implanted ( according to randomization )at the apex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV ejection fraction measured by radionuclide ventriculography (RVG). |  | 2 weeks, 24 months and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP). |  | 36 months | 
| 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 | 
| Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores. |  | 2 weeks, 24 and 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Permanent Pacemaker Implantation- Lead Position