Right Apical Versus Septal Pacing Trial (RASP)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Heart Block
• Intervention / Treatment: Device: Septal RV lead placement; Device: Apical RV lead placement

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Septal RV lead placement; patient randomized to Septal RV lead placement	Device: Septal RV lead placement; RV lead is implanted (according to randomization), on septum
ACTIVE_COMPARATOR: Apical RV lead placement; patient randomized to Apical RV lead placement (current standard placement)	Device: Apical RV lead placement; RV lead implanted ( according to randomization )at the apex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LV ejection fraction measured by radionuclide ventriculography (RVG).	2 weeks, 24 months and 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).	36 months
All cause mortality.	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
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
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
total implant procedure and fluoroscopy time	Implant

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Medtronic
• Investigators: Principal Investigator: Raymond Yee, MD FRCPC, Western University, Canada

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 20, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Permanent Pacemaker Implantation- Lead Position
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block
• Other Study ID Numbers: R-04-399; HSREB # 10880 (OTHER: UWO Ethics)