Mid-Q Response Study

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Study ID
NCT04180696
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aCRT ON — DEVICE
    CRT device with AdaptivCRT enabled
  • aCRT OFF — DEVICE
    CRT device with AdaptivCRT disabled

Study Details

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.

Key Dates

Start date
Jan 23, 2020
Status verified
Apr 2025
Primary completion
Mar 28, 2024
Completion
Mar 28, 2024

Study Design

Enrollment
177 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AdaptivCRT ON (aCRT ON, treatment group)
    AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
  • Active Comparator: AdaptivCRT OFF (aCRT OFF, control group)
    AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.

Primary Outcome Measure

Clinical Composite Score [ Time Frame: 6 months post-randomization ]

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