Sinus-node DysfunctionRVOTCARENCT01294839

Right Ventricular Outflow Tract Study

A study testing Right ventricular lead location in people with Sinus-node Dysfunction, run by Abbott Medical Devices at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sinus-node Dysfunction
What is being tested?: Right ventricular lead location
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: 1 siteChina
Study dates: Mar 2011to Jun 2016
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

China1 site

Guang Dong General Hospital
Guangzhou, Guangdong, 510030

Other trials in China

About this study

Official title: Right Ventricular Outflow Tract Septal Pacing for Cardiac Dysfunction Prevention Evaluation

Read the 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.

Conditions: Sinus-node Dysfunction
Being tested: Right ventricular lead location
Keywords: sinus-node dysfunction, RVOTs pacing, RVA pacing
Medical subject headings: Sick Sinus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Right ventricular lead locationDevice
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.

Study groups in NCT01294839
Study group	Role	What they receive
RVOTs	Experimental	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. Receives: Device: Right ventricular lead location
AAI	Experimental	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. Receives: Device: Right ventricular lead location
RVA	Active comparator	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. Receives: Device: Right ventricular lead location

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 18 months

Secondary outcomes (1)

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.
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jun 2016

First posted14 Feb 2011 (estimated)
Study startMar 2011
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sinus-node DysfunctionStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294839
Sponsor's protocol ID: CR-10-016-AP-LV
Acronym: RVOTCARE
Status last verified: Jan 2019
First submitted: 10 Feb 2011
Last updated: 4 Feb 2019
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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