Right Apical Versus Septal Pacing Trial (RASP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic of Canada
Information provided by (Responsible Party):
Dr. Raymond Yee, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00199498
First received: September 13, 2005
Last updated: May 1, 2012
Last verified: April 2012
  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 RV lead placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Estimated Enrollment: 160
Study Start Date: April 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Septal RV lead placement
patient randomized to Septal RV lead placement
Device: Permanent RV lead placement
RV lead placed at the randomized site
Active Comparator: Apical RV lead placement
patient randomized to Apical RV lead placement (current standard placement)
Device: Permanent RV lead placement
RV lead placed at the randomized site

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Dr. 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
Study First Received: September 13, 2005
Last Updated: May 1, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 16, 2014