Clinical Trial: Right Apical Versus Septal Pacing Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Summary:

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

Sponsor: Lawson Health Research Institute

Current Primary Outcome: LV ejection fraction measured by radionuclide ventriculography (RVG). [ Time Frame: 2 weeks, 24 months and 36 months ]

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

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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


Information By: Lawson Health Research Institute

Dates:
Date Received: September 13, 2005
Date Started: April 2005
Date Completion: December 2016
Last Updated: April 11, 2016
Last Verified: April 2016