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Right Apical Versus Septal Pacing Trial (RASP)

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ClinicalTrials.gov Identifier: NCT00199498
Recruitment Status : Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : April 13, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Block Heart Failure Device: Apical RV lead placement Device: Septal RV lead placement

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Right Apical Versus Septal Pacing Trial
Study Start Date : April 2005
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP). [ Time Frame: 36 months ]
  2. All cause mortality. [ Time Frame: 36 months ]
  3. Non-fatal thromboembolic events including stroke. [ Time Frame: 36 months ]
  4. Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic. [ Time Frame: 36 months ]
  5. Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation. [ Time Frame: 36 months ]
  6. Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores. [ Time Frame: 2 weeks, 24 and 36 months ]
  7. NYHA class using SAS survey, 6 minute hall walk distance. [ Time Frame: 2 weeks, 24 and 36 months ]
  8. lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold [ Time Frame: 2 weeks, 24 and 36 months ]
  9. total implant procedure and fluoroscopy time [ Time Frame: Implant ]

Eligibility Criteria

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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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00199498     History of Changes
Other Study ID Numbers: R-04-399
HSREB # 10880 ( Other Identifier: UWO Ethics )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Raymond Yee, 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