Right Ventricular Outflow Tract Study

Sinus-node Dysfunction Clinical Trial

— RVOTCARE  

Official title:

Right Ventricular Outflow Tract Septal Pacing for Cardiac Dysfunction Prevention Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294839
• Other study ID #: CR-10-016-AP-LV
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: June 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.

Description:

Ventricular pacing is unavoidable in many patients because of unreliable or absent AV conduction, or permanent AF. In recognition of this need, interest has focused on alternative site(s) ventricular pacing to maximize pumping function. These sites include the RV septum, His bundle, various LV sites, and combination of LV and RV (biventricular [BiV]). The RV outflow tract septum (RVOTs) seems to be the most promising site within the RV.

However, small enrollment and inconsistent experimental methods hinder the interpretation of these studies. Locations of alternative pacing sites were not clearly specified, were largely topographic, and lacked consistent anatomic designation. And what is more, there was no prospective, double-blind randomized, multi-center clinical trial which is design to test whether RVOTs pacing is superior to right ventricular apical pacing in preserving left ventricular systolic function and avoiding adverse left ventricular remodeling in patients with a normal left ventricular ejection fraction, ventricular synchrony and standard indications for pacing (sinus node dysfunction) in China. There was also no prospective, double-blind randomized, multi-center clinical trial which is design to test whether RVOTs pacing is not inferior to AAIR pacing in preserving left ventricular systolic function and avoiding adverse left ventricular remodeling in patients with a normal left ventricular ejection fraction, ventricular synchrony and sinus node dysfunction in the world.

So SJM China will sponsor a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with only sinus-node dysfunction and meet pacing indication

• Patients with LVEF=60% and with ventricular synchrony.

• Patients signed the written informed consent for the study

• Patients can endure the required follow up

Exclusion Criteria:

• Patients with atrial fibrillation

• Patients with atrial-ventricular block

• Patients with LBBB

• Patients with significant valvular disease

• Patients with severe hematopathy or severe renal inadequacy

• Patients with life expectancy < 1.5 year

• Patients who are in the period of pregnant or lactation

• Patients who are younger than 18 years old

• Patients who are ongoing other devices or agents study

Related Conditions & MeSH terms

• Sick Sinus Syndrome
• Sinus-node Dysfunction

Intervention

Device:
• Right ventricular lead location
RV leads in RVOTs group will be located in right ventricular outflow tract septum, RV leads in the other two group will be implanted in right ventricular apex, for the last RVOTs and RVA groups, the accumulated ventricular pacrouping percentage should be over 80% by adjusting AV delays.

Locations

Country	Name	City	State
China	Guang Dong General Hospital	Guang Zhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF)	To demonstrate: Whether RVOTs pacing is superior to right ventricular apical pacing in preserving left ventricular systolic function in patients with a normal left ventricular ejection fraction, ventricular synchrony and standard indications for pacing(sinus node dysfunction); Whether RVOTs pacing is not inferior to AAI pacing in preserving left ventricular systolic function in patients with a normal left ventricular ejection fraction, ventricular synchrony and sinus node dysfunction.	18 months
Secondary	left ventricular end-systolic volume (LVESV)	To demonstrate: Whether RVOTs pacing is superior to right ventricular apical pacing in avoiding adverse left ventricular remodeling in patients with a normal left ventricular ejection fraction, ventricular synchrony and standard indications for pacing(sinus node dysfunction); Whether RVOTs pacing is not inferior to AAI pacing in avoiding adverse left ventricular remodeling in patients with a normal left ventricular ejection fraction, ventricular synchrony and sinus node dysfunction.	18 months