Right Ventricular Outflow Tract Study (RVOTCARE)

Right Ventricular Outflow Tract Septal Pacing for Cardiac Dysfunction Prevention Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Sinus-node Dysfunction
• Intervention / Treatment: Device: Right ventricular lead location

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guang Zhou, Guangdong, China, 510030
      • Guang Dong General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RVOTs; 555 Patients will be randomized to three groups(RVOTs, RVA, AAI) in 1:1:1, 185 patients in RVOTs arm, the RV lead of this group patients will be implanted in right ventricular outflow tract septum,the accumulated ventricular pacing percentage should be over 80% by adjusting AV delays.	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.
Experimental: AAI; 555 Patients will be randomized to three groups(RVOTs, RVA, AAI) in 1:1:1, 185 patients in AAI arm, the RV lead of this group patients will be implanted in right ventricular apex.	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.
Active Comparator: RVA; 555 Patients will be randomized to three groups(RVOTs, RVA, AAI) in 1:1:1, 185 patients in RVA arm, the RV lead of this group patients will be implanted in right ventricular apex, the accumulated ventricular pacing percentage should be over 80% by adjusting AV delays.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: sinus-node dysfunction; RVOTs pacing; RVA pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Sick Sinus Syndrome
• Other Study ID Numbers: CR-10-016-AP-LV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No