Right Apical Versus Septal Pacing Trial

Heart Failure Clinical Trial

— RASP  

Official title:

Right Apical Versus Septal Pacing Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00199498
• Other study ID #: R-04-399
• Secondary ID: HSREB # 10880
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: April 11, 2016
• Start date: April 2005
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Block
• Heart Failure

Intervention

Device:
• Apical RV lead placement
RV lead implanted ( according to randomization )at the apex
• Septal RV lead placement
RV lead is implanted (according to randomization), on septum

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV ejection fraction measured by radionuclide ventriculography (RVG).		2 weeks, 24 months and 36 months	Yes
Secondary	Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).		36 months	Yes
Secondary	All cause mortality.		36 months	Yes
Secondary	Non-fatal thromboembolic events including stroke.		36 months	Yes
Secondary	Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic.		36 months	Yes
Secondary	Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation.		36 months	Yes
Secondary	Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores.		2 weeks, 24 and 36 months	Yes
Secondary	NYHA class using SAS survey, 6 minute hall walk distance.		2 weeks, 24 and 36 months	Yes
Secondary	lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold		2 weeks, 24 and 36 months	Yes
Secondary	total implant procedure and fluoroscopy time		Implant	Yes