Right Apical Versus Septal Pacing Trial

NCT00199498 | Unknown

• 2 other identifiers: R-04-399HSREB # 10880
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Block; Heart Failure

Keywords

Permanent Pacemaker Implantation- Lead Position

Outcome Measures

Primary Outcomes (1)

• LV ejection fraction measured by radionuclide ventriculography (RVG).

  2 weeks, 24 months and 36 months

Secondary Outcomes (9)

• 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

Study Arms (2)

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

Apical RV lead placement DEVICE

RV lead implanted ( according to randomization )at the apex

Apical RV lead placement

Septal RV lead placement DEVICE

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

Septal RV lead placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Medtronic: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Heart Block; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raymond Yee, MD FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Raymond Yee MD FRCPC

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

CA (1)