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Right Apical Versus Septal Pacing Trial
This study is currently recruiting participants.
Verified by Lawson Health Research Institute, April 2009
First Received: September 13, 2005   Last Updated: April 20, 2009   History of Changes
Sponsor: Lawson Health Research Institute
Collaborator: Medtronic
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00199498
  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 Pacemaker Implantation

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Right Apical Versus Septal Pacing Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 ]
  • 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 ]

Estimated Enrollment: 160
Study Start Date: April 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
patient randomized to Septal RV lead placement
Device: Permanent Pacemaker Implantation
routine pacemaker implantation with RV lead placed at the randomized site
2: Active Comparator
patient randomized to Apical RV lead placement (current standard placement)
Device: Permanent Pacemaker Implantation
routine pacemaker implantation with 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199498

Contacts
Contact: Raymond Yee, MD FRCPC 519-685-8500 ext 33746 ryee@uwo.ca
Contact: Kathy Blackler 519-685-8500 ext 32569 kblackle@uwo.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Kathy Blackler     519-685-8500 ext 32569     kblackle@uwo.ca    
Contact: Cathy Bentley     519-685-8500 ext 32835     cbentl@uwo.ca    
Principal Investigator: Raymond Yee, MD FRCPC            
Sponsors and Collaborators
Lawson Health Research Institute
Medtronic
Investigators
Principal Investigator: Raymond Yee, MD FRCPC University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: London Health Sciences Centre- Lawson Health Research Institute ( Dr.Raymond Yee )
Study ID Numbers: R-04-399, 10880
Study First Received: September 13, 2005
Last Updated: April 20, 2009
ClinicalTrials.gov Identifier: NCT00199498     History of Changes
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Heart Failure
Pathologic Processes
Heart Diseases
 Heart Block
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 25, 2009



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