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Right Ventricular Outflow Tract Study (RVOTCARE)

Primary Purpose

Sinus-node Dysfunction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Right ventricular lead location
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus-node Dysfunction focused on measuring sinus-node dysfunction, RVOTs pacing, RVA pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guang Dong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

RVOTs

AAI

RVA

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 10, 2011
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01294839
Brief Title
Right Ventricular Outflow Tract Study
Acronym
RVOTCARE
Official Title
Right Ventricular Outflow Tract Septal Pacing for Cardiac Dysfunction Prevention Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus-node Dysfunction
Keywords
sinus-node dysfunction, RVOTs pacing, RVA pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RVOTs
Arm Type
Experimental
Arm Description
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.
Arm Title
AAI
Arm Type
Experimental
Arm Description
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.
Arm Title
RVA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Right ventricular lead location
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF)
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
left ventricular end-systolic volume (LVESV)
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Guang Dong General Hospital
City
Guang Zhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China

12. IPD Sharing Statement

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Right Ventricular Outflow Tract Study

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