Right Apical Versus Septal Pacing Trial (RASP)

Lawson Health Research Institute

Status: Unknown

Conditions: Heart Failure; Heart Block

Treatments: Device: Septal RV lead placement; Device: Apical RV lead placement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00199498

HSREB # 10880 (Other Identifier)

R-04-399

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Septal RV lead placement

Experimental group

Description:

patient randomized to Septal RV lead placement

Treatment:

Device: Septal RV lead placement

Apical RV lead placement

Active Comparator group

Description:

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

Treatment:

Device: Apical RV lead placement