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Mid-Q Response Study

NCT04180696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2025-07-09

Study results available
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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

DEVICE

aCRT ON

CRT device with AdaptivCRT enabled

DEVICE

aCRT OFF

CRT device with AdaptivCRT disabled

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Japan Co., Ltd.

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Kazutaka Aonuma, MD · University of Tsukuba Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-23
Primary Completion
2024-03-28
Completion
2024-03-28

Countries

  • Brunei
  • China
  • Hong Kong
  • Indonesia
  • Japan
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180696 on ClinicalTrials.gov