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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00199498
Other study ID # R-04-399
Secondary ID HSREB # 10880
Status Active, not recruiting
Phase N/A
First received September 13, 2005
Last updated April 11, 2016
Start date April 2005
Est. completion date December 2016

Study information

Verified date April 2016
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 160
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Apical RV lead placement
RV lead implanted ( according to randomization )at the apex
Septal RV lead placement
RV lead is implanted (according to randomization), on septum

Locations

Country Name City State
Canada London Health Sciences Centre London Ontario

Sponsors (2)

Lead Sponsor Collaborator
Lawson Health Research Institute Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

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