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Right Apical Versus Septal Pacing Trial

This study is currently recruiting participants.
Study NCT00199498.   Last updated on September 13, 2005.   Information provided by Lawson Health Research Institute

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Right Apical Versus Septal Pacing Trial
Official Title † Right Apical Versus Septal Pacing Trial
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
Study Phase
Study Type † Interventional
Study Design † Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure † LV ejection fraction measured by radionuclide ventriculography (RVG).
Secondary Outcome Measure † 1. left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP)
2. all cause mortality
3.non-fatal thromboembolic events including stroke
4.heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic
5.occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation
6. symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores
7. NYHA class using SAS survey, 6 minute hall walk distance
8. serum brain natriuretic peptide level (BNP), which has been shown to be elevated in ventricular paced patients
9. lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold
10. total implant procedure and flouroscopy time
Condition † Heart Block
Heart Failure
Intervention † Device: Permanent Pacemaker Implantation
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 160
Start Date † April 2005
Completion Date December 2008
Eligibility Criteria †

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
  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 -
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Raymond Yee, MD FRCPC     519-685-8500 ext 33746     ryee@uwo.ca    
Contact: Steve Saunders     519-685-8500 ext 36341     ssaunder6@uwo.ca    
Location Countries † Canada
Administrative Information Fields
NCT ID † NCT00199498
Organization ID RASP
Secondary IDs ††
Study Sponsor † Lawson Health Research Institute
Collaborators †† Medtronic
Investigators †
Principal Investigator:     Raymond Yee, MD FRCPC     University of Western Ontario, Canada    
Information Provided By Lawson Health Research Institute
Verification Date September 2005
First Received Date † September 13, 2005
Last Updated Date September 13, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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