Clinical trial NCT00199498: Right Apical Versus Septal Pacing Trial
Official title: Right Apical Versus Septal Pacing Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Block
Heart Failure
Keywords: Permanent Pacemaker Implantation- Lead Position
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2005-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: LV ejection fraction measured by radionuclide ventriculography (RVG).
timeFrame: 2 weeks, 24 months and 36 months
Secondary outcomes:
measure: Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).
timeFrame: 36 months
measure: All cause mortality.
timeFrame: 36 months
measure: Non-fatal thromboembolic events including stroke.
timeFrame: 36 months
measure: Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic.
timeFrame: 36 months
measure: Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation.
timeFrame: 36 months
measure: Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores.
timeFrame: 2 weeks, 24 and 36 months
measure: NYHA class using SAS survey, 6 minute hall walk distance.
timeFrame: 2 weeks, 24 and 36 months
measure: lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold
timeFrame: 2 weeks, 24 and 36 months
measure: total implant procedure and fluoroscopy time
timeFrame: Implant
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Raymond Yee, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: