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Right Apical Versus Septal Pacing Trial

This study is currently recruiting participants.
Verified by Lawson Health Research Institute, September 2005

Sponsors and Collaborators: Lawson Health Research Institute
Medtronic
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00199498
  Purpose

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.


Condition Intervention
Heart Block
Heart Failure
Device: Permanent Pacemaker Implantation

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Right Apical Versus Septal Pacing Trial

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • LV ejection fraction measured by radionuclide ventriculography (RVG).

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   160
Study Start Date:   April 2005
Estimated Study Completion Date:   December 2008

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
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 -
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199498

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    

Locations
Canada, Ontario
London Health Sciences Centre     Recruiting
      London, Ontario, Canada, N6A 5A5
      Contact: Steve Saunders     519-685-8500 ext 36341     ssaunder6@uwo.ca    
      Contact: Kathy Blackler     510-685-8500 ext 32569     kblackle@uwo.ca    
      Principal Investigator: Raymond Yee, MD FRCPC            

Sponsors and Collaborators
Lawson Health Research Institute
Medtronic

Investigators
Principal Investigator:     Raymond Yee, MD FRCPC     University of Western Ontario, Canada    
  More Information

Study ID Numbers:   RASP
First Received:   September 13, 2005
Last Updated:   September 13, 2005
ClinicalTrials.gov Identifier:   NCT00199498
Health Authority:   Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Permanent Pacemaker Implantation- Lead Position  

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Heart Block
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2008




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