Right Ventricular Outflow Tract Study (RVOTCARE)

This study is currently recruiting participants. (see Contacts and Locations)
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

February 10, 2011
January 9, 2013
March 2011
June 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01294839 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Right Ventricular Outflow Tract Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sinus-node Dysfunction
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: 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.
    Intervention: Device: Right ventricular lead location
  • 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.
    Intervention: Device: Right ventricular lead location
  • 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.
    Intervention: Device: Right ventricular lead location
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
555
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
China
 
NCT01294839
CR-10-016-AP-LV
Yes
Bailleul Christophe/ Vice President Clinical Operations International Division, St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP