This trial is active, not recruiting.

Condition bradycardia
Treatment crt
Sponsor St. Jude Medical
Start date February 2012
End date July 2016
Trial size 177 participants
Trial identifier NCT01559311, CR-10-003-AP-HF


The purpose of this clinical project is to evaluate the efficacy of the presence of RVA pacing induced ventricular dyssynchrony as a guiding parameter for bi-ventricular pacing in patients with bradycardia and normal left ventricular ejection fraction (LVEF). The results of this project may provide with the evidence based medicine for guidelines expansion of using CRT in patients with Heart Block and normal LVEF (LVEF >45%).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
(No Intervention)
(No Intervention)
crt Implantation of LV lead
CRT Implant

Primary Outcomes

Left ventricular ejection fraction (LVEF)
time frame: 12 months
Left ventricular end-systolic volume
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient meets current indications for implantation of a DDDR pacemaker - Patient is geographically stable and willing to comply with the required follow-up schedule Exclusion Criteria: - Patient has unstable angina or an acute coronary syndrome - Patient has undergone percutaneous coronary intervention or coronary artery bypass surgery within the previous 3 months - Patient's life expectancy is less than 1 year - Patient is less than 18 years old - Patient is pregnant - Patient has received a heart transplant

Additional Information

Official title Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction
Principal investigator Cheuk Man Yu, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by St. Jude Medical.