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Right Apical Versus Septal Pacing Trial
This study is currently recruiting participants.
Study NCT00199498   Information provided by Lawson Health Research Institute
First Received: September 13, 2005   Last Updated: April 20, 2009   History of Changes

September 13, 2005
April 20, 2009
April 2005
July 2012   (final data collection date for primary outcome measure)
LV ejection fraction measured by radionuclide ventriculography (RVG). [ Time Frame: 2 weeks, 24 months and 36 months ] [ Designated as safety issue: Yes ]
LV ejection fraction measured by radionuclide ventriculography (RVG).
Complete list of historical versions of study NCT00199498 on ClinicalTrials.gov Archive Site
  • Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP). [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • All cause mortality. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Non-fatal thromboembolic events including stroke. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores. [ Time Frame: 2 weeks, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • NYHA class using SAS survey, 6 minute hall walk distance. [ Time Frame: 2 weeks, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • Serum brain natriuretic peptide level (BNP), which has been shown to be elevated in ventricular paced patients [ Time Frame: 2 weeks, 24 and 36 months ] [ Designated as safety issue: No ]
  • lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold [ Time Frame: 2 weeks, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • total implant procedure and fluoroscopy time [ Time Frame: Implant ] [ Designated as safety issue: Yes ]
  • 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
 
Right Apical Versus Septal Pacing Trial
Right Apical Versus Septal Pacing Trial

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
 
Interventional
Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
  • Heart Block
  • Heart Failure
Device: Permanent Pacemaker Implantation
  • Experimental: patient randomized to Septal RV lead placement
  • Active Comparator: patient randomized to Apical RV lead placement (current standard placement)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
160
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Raymond Yee, MD FRCPC 519-685-8500 ext 33746 ryee@uwo.ca
Contact: Kathy Blackler 519-685-8500 ext 32569 kblackle@uwo.ca
Canada
 
NCT00199498
Dr.Raymond Yee, London Health Sciences Centre- Lawson Health Research Institute
R-04-399, 10880
Lawson Health Research Institute
Medtronic
Principal Investigator: Raymond Yee, MD FRCPC University of Western Ontario, Canada
Lawson Health Research Institute
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP