N/A N=98 Randomized Single-blind Prevention

ENHANCE-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

Bradycardia

Bottom Line

View on ClinicalTrials.gov: NCT01559311 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Oct 2016

Primary outcome: Primary: LVEF — 64.22; 63.14; 59.96 % LVEF — p=0.1734

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CRT-P OFF (Device); CRT-P ON (Device); DDDR (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY LVEF	64.22; 63.14; 59.96	0.1734
PRIMARY LVESV	30.52; 34.54; 36.38	0.6276

Summary

The purpose of this clinical project is to evaluate the efficacy of the presence of Right Ventricular Apical (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 Cardiac resynchronization therapy (CRT) in patients with Heart Block and normal LVEF (LVEF >45%).

Eligibility Criteria

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
Patient has LVEF >45%
Patient has atrioventricular block (IIo or above)
Patient has adequate echocardiographic images to measure LV volumes and LVEF

Exclusion Criteria

Patient has permanent atrial fibrillation (AF)
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

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Data sourced from ClinicalTrials.gov (NCT01559311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.