Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study

Bradyarrhythmia Clinical Trial

— RIVELA  

Official title:

Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01535404
• Other study ID #: CRM-CH-Riv01
• Status: Terminated
• Phase: N/A
• First received: February 10, 2012
• Last updated: May 11, 2016
• Start date: January 2012
• Est. completion date: May 2016

Study information

• Verified date: October 2014
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (>= 45%).

Description:

It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)

• Anticipated >=50% daily ventricular pacing

• LVEF >=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography

• Minimum age of 18 years, and at least 1 year life expectancy

Exclusion Criteria:

• Prior tricuspid valve replacement (annuloplasty is permitted)

• Intrinsic rhythm < 30bpm

• Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.

• Echocardiographic window of insufficient quality for measuring LVEF

• Life expectancy of < 1year

• Pregnancy (women of childbearing potential will undergo pregnancy testing)

• Unable of unwilling to sign a patient informed consent form

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia

Intervention

Device:
• Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing
Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead
• Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing
Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead

Locations

Country	Name	City	State
Netherlands	Cardiovascular Research Institute, University of Maastricht	Maastricht
Switzerland	University Hospital of Basel	Basel	BS
Switzerland	University Hospital Geneva	Geneva	GE
Switzerland	Cardiocentro Ticino (Lugano)	Lugano	TI
Switzerland	Kantonsspital Luzern	Luzern	LU
Switzerland	Kantonsspital St-Gallen	St-Gallen	SG

Sponsors (2)

Lead Sponsor	Collaborator
Haran Burri, MD	St. Jude Medical

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in LVEF		baseline to one year	No
Secondary	Change in left ventricular end-systolic and end-diastolic volumes		one year	No
Secondary	Dyssynchrony evaluation during RV and LV pacing		one year	No
Secondary	Change in tricuspid regurgitation severity, if any		one year	No
Secondary	Change in mitral regurgitation severity, if any		one year	No
Secondary	Incidence of device-related complications		one year	Yes
Secondary	Success rate of autocapture algorithm for left-and right-ventricular pacing		one year	Yes
Secondary	Mortality and all cause hospitalization		one year	No
Secondary	Reduction of LVEF at 1 year compared to baseline according to the following pre-specified subgroups: a) initial LVEF, b) gender, c)etiology (coronary artery disease, nonischemic cardiomyopathy)		one year	No