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Right Ventricular Outflow Tract Study (RVOTCARE)

This study is currently recruiting participants.
Verified January 2013 by St. Jude Medical
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01294839
First received: February 10, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Sinus-node Dysfunction
 Device: Right ventricular lead location

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RIGHT VENTRICULAR OUTFLOW TRACT SEPTAL PACING FOR CARDIAC DYSFUNCTION PREVENTION EVALUATION

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Left ventricular ejection fraction (LVEF) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 555
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294839

Contacts
Contact: Lin Sh Wu, MD +86 20 83827812 ext 10290 wushulin8888@yahoo.com.cn
Contact: Lin Si Chen, MD +86 20 83827812 ext 10525 chen.silin@tom.com

Locations
China, Guangdong
Guang Dong General Hospital Recruiting
Guang Zhou, Guangdong, China, 510030
Contact: Lin Sh Wu, MD     +86 20 83827812 ext 10290     wushulin8888@yahoo.com.cn    
Contact: Lin Si Chen, MD     +86 20 83827812 ext 10525     chen.silin@tom.com    
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: Bailleul Christophe/ Vice President Clinical Operations International Division, St. Jude Medical
ClinicalTrials.gov Identifier: NCT01294839     History of Changes
Other Study ID Numbers: CR-10-016-AP-LV
Study First Received: February 10, 2011
Last Updated: January 9, 2013
Health Authority: China: Ethics Committee

Keywords provided by St. Jude Medical:
sinus-node dysfunction
RVOTs pacing
RVA pacing

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013