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Right Apical Versus Septal Pacing Trial (RASP)

Primary Purpose

Heart Block, Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Apical RV lead placement
Septal RV lead placement
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Block focused on measuring Permanent Pacemaker Implantation- Lead Position

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 the subject is 18 years of age or older the subject has provided written consent - Exclusion Criteria: Pre-existing permanent cardiac pacemaker or ICD (defibrillator) Presence of Hypertrophic Obstructive Cardiomyopathy Recent cardiac surgery (</= 30 days) Recent myocardial infarction (</= 30 days) Presence of mechanical prosthetic tricuspid valve Patient inability or unwillingness to comply with study protocol and required study visit schedule Concomitant research study whose protocol would conflict or affect the outcome of this study Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Septal RV lead placement

Apical RV lead placement

Arm Description

patient randomized to Septal RV lead placement

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

Outcomes

Primary Outcome Measures

LV ejection fraction measured by radionuclide ventriculography (RVG).

Secondary Outcome Measures

Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).
All cause mortality.
Non-fatal thromboembolic events including stroke.
Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic.
Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation.
Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores.
NYHA class using SAS survey, 6 minute hall walk distance.
lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold
total implant procedure and fluoroscopy time

Full Information

First Posted
September 13, 2005
Last Updated
April 11, 2016
Sponsor
Lawson Health Research Institute
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00199498
Brief Title
Right Apical Versus Septal Pacing Trial
Acronym
RASP
Official Title
Right Apical Versus Septal Pacing Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: to compare the effect of RVSeptal(RVS) versus RVApical(RVA)pacing on other indices of systolic and diastolic LV function to compare the rate of heart failure-related hospitalization between RVS versus RVA pacing to compare new-onset atrial fibrillation and stroke rates between RVS versus RVA pacing to assess the effect of RVA versus RVS pacing on quality of life and functional capacity to compare the rate of successful pacemaker lead implantation, complications and chronic electrical performance of RVS versus RVA pacing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Block, Heart Failure
Keywords
Permanent Pacemaker Implantation- Lead Position

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Septal RV lead placement
Arm Type
Experimental
Arm Description
patient randomized to Septal RV lead placement
Arm Title
Apical RV lead placement
Arm Type
Active Comparator
Arm Description
patient randomized to Apical RV lead placement (current standard placement)
Intervention Type
Device
Intervention Name(s)
Apical RV lead placement
Intervention Description
RV lead implanted ( according to randomization )at the apex
Intervention Type
Device
Intervention Name(s)
Septal RV lead placement
Intervention Description
RV lead is implanted (according to randomization), on septum
Primary Outcome Measure Information:
Title
LV ejection fraction measured by radionuclide ventriculography (RVG).
Time Frame
2 weeks, 24 months and 36 months
Secondary Outcome Measure Information:
Title
Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).
Time Frame
36 months
Title
All cause mortality.
Time Frame
36 months
Title
Non-fatal thromboembolic events including stroke.
Time Frame
36 months
Title
Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic.
Time Frame
36 months
Title
Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation.
Time Frame
36 months
Title
Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores.
Time Frame
2 weeks, 24 and 36 months
Title
NYHA class using SAS survey, 6 minute hall walk distance.
Time Frame
2 weeks, 24 and 36 months
Title
lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold
Time Frame
2 weeks, 24 and 36 months
Title
total implant procedure and fluoroscopy time
Time Frame
Implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 the subject is 18 years of age or older the subject has provided written consent - Exclusion Criteria: Pre-existing permanent cardiac pacemaker or ICD (defibrillator) Presence of Hypertrophic Obstructive Cardiomyopathy Recent cardiac surgery (</= 30 days) Recent myocardial infarction (</= 30 days) Presence of mechanical prosthetic tricuspid valve Patient inability or unwillingness to comply with study protocol and required study visit schedule Concomitant research study whose protocol would conflict or affect the outcome of this study Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Yee, MD FRCPC
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

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Right Apical Versus Septal Pacing Trial

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