NCT03089281

Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 699 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

Detailed description

The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CRT-D	Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-09-15
• Completion: 2020-09-15
• First posted: 2017-03-24
• Last updated: 2022-04-05
• Results posted: 2022-04-05

Locations

72 sites across 11 countries: United States, Canada, France, Germany, Ireland, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study