Right Apical Versus Septal Pacing Trial

N/AUnknownNCT00199498

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's160 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

160

Conditions

Heart Block Heart Failure

Interventions

Apical RV lead placementDEVICE

RV lead implanted ( according to randomization )at the apex

Septal RV lead placementDEVICE

RV lead is implanted (according to randomization), on septum

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

LV ejection fraction measured by radionuclide ventriculography (RVG).

Time frame: 2 weeks, 24 months and 36 months

Secondary Outcomes

Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).

Time frame: 36 months

All cause mortality.

Time frame: 36 months

Non-fatal thromboembolic events including stroke.

Time frame: 36 months

Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic.

Time frame: 36 months

Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation.

Time frame: 36 months

Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores.

Time frame: 2 weeks, 24 and 36 months

NYHA class using SAS survey, 6 minute hall walk distance.

Time frame: 2 weeks, 24 and 36 months

lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold

Time frame: 2 weeks, 24 and 36 months

total implant procedure and fluoroscopy time

Time frame: Implant

Data from ClinicalTrials.gov

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