Right Apical Versus Septal Pacing Trial | NCT00199498

Studies
Right Apical Versus Septal Pacing Trial

NCT00199498

Sponsor

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

Status

Unknown status

Last Update Posted

Apr 13, 2016Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Heart Block
Heart Failure

Interventions

Apical RV lead placement
Septal RV lead placement

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HSREB # 10880	Other Identifier	UWO Ethics

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2016

Last Update Posted Date

Apr 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raymond Yee, Dr.Raymond Yee MD FRCPC, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Septal RV lead placement	Experimental	patient randomized to Septal RV lead placement	Device: Septal RV lead placement
Apical RV lead placement	Active Comparator	patient randomized to Apical RV lead placement (current standard placement)	Device: Apical RV lead placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apical RV lead placement	Device	RV lead implanted ( according to randomization )at the apex	Apical RV lead placement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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 (\

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raymond Yee, MD FRCPC	Western University, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario	N6A 5A5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D006327	Heart Block
D006333	Heart Failure

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

Browse Leaves

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Browse Branches

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