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Status unknownNCT00199498RASPUpdated Apr 13, 2016

Right Apical Versus Septal Pacing Trial

An interventional study of Apical RV lead placement and Septal RV lead placement in Heart Block and Heart Failure, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-13.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Heart Block
  • Heart Failure

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Keywords

  • Permanent Pacemaker Implantation- Lead Position
03

In context

Heart Block

72 studies on the registry are indexed under Heart Block; 18 are open to participants now.

This study's planned enrollment of 160 is above the median of 89 across 40 interventional studies indexed under Heart Block.

Browse Heart Block studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Septal RV lead placement

    patient randomized to Septal RV lead placement

    Device: Septal RV lead placement

  • Active comparator
    Apical RV lead placement

    patient randomized to Apical RV lead placement (current standard placement)

    Device: Apical RV lead placement

Interventions

  • DeviceApical RV lead placement

    RV lead implanted ( according to randomization )at the apex

  • DeviceSeptal RV lead placement

    RV lead is implanted (according to randomization), on septum

06

What researchers measure

Primary outcomes

  1. LV ejection fraction measured by radionuclide ventriculography (RVG).

    Time frame: 2 weeks, 24 months and 36 months

Secondary outcomes

  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

07

Study locations

1 site
  • London Health Sciences Centre
    London, Ontario N6A 5A5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00199498
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Collaborators
Medtronic
Responsible party
Raymond Yee (Dr.Raymond Yee MD FRCPC, London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Sep 20, 2005
Start date
Apr 2005
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Apr 13, 2016

Study contacts

Raymond Yee, MD FRCPC
principal investigator · Western University, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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