Right Apical Versus Septal Pacing Trial

NCT ID: NCT00199498

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2016-12-31

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

Conditions

Heart Block; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Septal RV lead placement

patient randomized to Septal RV lead placement

Group Type: EXPERIMENTAL

Septal RV lead placement

Intervention Type: DEVICE

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

Apical RV lead placement

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

Group Type: ACTIVE_COMPARATOR

Apical RV lead placement

Intervention Type: DEVICE

RV lead implanted ( according to randomization )at the apex

Interventions

Apical RV lead placement

RV lead implanted ( according to randomization )at the apex

Intervention Type: DEVICE

Septal RV lead placement

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Raymond Yee

Dr.Raymond Yee MD FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond Yee, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

HSREB # 10880

Identifier Type: OTHER

Identifier Source: secondary_id

R-04-399

Identifier Type: -

Identifier Source: org_study_id