This trial is active, not recruiting.

Conditions heart block, heart failure
Treatment permanent rv lead placement
Sponsor Lawson Health Research Institute
Collaborator Medtronic of Canada
Start date April 2005
End date July 2015
Trial size 160 participants
Trial identifier NCT00199498, HSREB # 10880, R-04-399


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
patient randomized to Septal RV lead placement
permanent rv lead placement
RV lead placed at the randomized site
(Active Comparator)
patient randomized to Apical RV lead placement (current standard placement)
permanent rv lead placement
RV lead placed at the randomized site

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. a)Fixed (third degree) AV block b) Atrial Fibrillation with average Ventricular rate on ECG /= 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 (

Additional Information

Official title Right Apical Versus Septal Pacing Trial
Principal investigator Raymond Yee, MD FRCPC
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.