NCT04180696

Mid-Q Response Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study. The purpose of the Mid-Q Response study is to test the hypothesis that the AdaptivCRT (aCRT) algorithm is superior to standard CRT therapy regarding patient outcomes in CRT indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction and left bundle branch block (LBBB). The study will be executed at approximately 60 centers in Asia. The subjects will be randomly assigned in a 1:1 ratio to the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Nonadaptive CRT) group. The primary objective is to test the hypothesis that aCRT ON increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF at 6 months of follow-up.

Conditions

• Heart Failure
• Left Bundle-Branch Block
• Heart Failure With Reduced Ejection Fraction (HFrEF)
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Interventions

Type	Name	Description
DEVICE	aCRT ON	CRT device with AdaptivCRT enabled
DEVICE	aCRT OFF	CRT device with AdaptivCRT disabled

Timeline

• Start date: 2020-01-23
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2019-11-27
• Last updated: 2025-07-09
• Results posted: 2025-05-30

Locations

61 sites across 10 countries: Brunei, China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan