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Right Apical Versus Septal Pacing Trial (RASP)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Raymond Yee, Lawson Health Research Institute Identifier:
First received: September 13, 2005
Last updated: April 11, 2016
Last verified: April 2016
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: Apical RV lead placement
Device: Septal RV lead placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Right Apical Versus Septal Pacing Trial

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: April 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Septal RV lead placement
patient randomized to Septal RV lead placement
Device: Septal RV lead placement
RV lead is implanted (according to randomization), on septum
Active Comparator: Apical RV lead placement
patient randomized to Apical RV lead placement (current standard placement)
Device: Apical RV lead placement
RV lead implanted ( according to randomization )at the apex

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00199498

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Raymond Yee, MD FRCPC University of Western Ontario, Canada
  More Information

Responsible Party: Raymond Yee, Dr.Raymond Yee MD FRCPC, Lawson Health Research Institute Identifier: NCT00199498     History of Changes
Other Study ID Numbers: R-04-399
HSREB # 10880 ( Other Identifier: UWO Ethics )
Study First Received: September 13, 2005
Last Updated: April 11, 2016

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

Additional relevant MeSH terms:
Heart Failure
Heart Block
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes processed this record on April 28, 2017