Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00199498
NCT00199498UnknownNot Applicable

Right Apical Versus Septal Pacing Trial

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 sites in 1 country160 target enrollmentStarted: April 1, 2005Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
160
Locations
2
Primary Endpoint
LV ejection fraction measured by radionuclide ventriculography (RVG).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •1. a)Fixed (third degree) AV block b) Atrial Fibrillation with average Ventricular rate on ECG \/= 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

  • •Pre-existing permanent cardiac pacemaker or ICD (defibrillator)
  • •Presence of Hypertrophic Obstructive Cardiomyopathy
  • •Recent cardiac surgery (</= 30 days)
  • •Recent myocardial infarction (</= 30 days)
  • •Presence of mechanical prosthetic tricuspid valve
  • •Patient inability or unwillingness to comply with study protocol and required study visit schedule
  • •Concomitant research study whose protocol would conflict or affect the outcome of this study
  • •Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition

Outcomes

Primary Outcomes

LV ejection fraction measured by radionuclide ventriculography (RVG).

Time Frame: 2 weeks, 24 months and 36 months

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Raymond Yee

Dr.Raymond Yee MD FRCPC

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Sites (2)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Right Ventricular Septal Versus Apical Pacing: Echocardiographic StudyPacemaker DDD
NCT06045143Assiut University54
Unknown
Not Applicable
RV Septal Versus Minimized RV Pacing in Sick Sinus SyndromeSick Sinus Syndrome
NCT01477138Klinikum Nürnberg126
Unknown
Phase 4
Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular BlockAtrio-Ventricular Block
NCT00709774Osaka General Medical Center60
Terminated
Not Applicable
Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)Right Bundle-Branch BlockHeart Failure
NCT02441101Barry London6
Terminated
Not Applicable
Impact of Septal Vs Apical Pacing on Right and Left Ventricular PerformanceHeart BlockVentricular DysfunctionAtrioventricular BlockSick Sinus Syndrome
NCT01798043Abbott Medical Devices29
Right Apical Versus Septal Pacing Trial | Clinical Trial