Trial results for the Mid-Q Response study in Heart Failure patients were posted on ClinicalTrials.gov on 2025-05-30, indicating that the AdaptivCRT algorithm was not statistically superior to standard CRT therapy among 177 enrolled participants.
Background
Heart failure is a chronic, progressive condition that affects the heart's ability to pump blood effectively. Patients with heart failure, particularly those with a reduced ejection fraction (HFrEF) and a left bundle-branch block (LBBB), often benefit from Cardiac Resynchronization Therapy (CRT). CRT involves implanting a device to help the heart's ventricles beat in a more synchronized way, improving pumping efficiency. The Mid-Q Response study aimed to investigate whether the AdaptivCRT (aCRT) algorithm, an advanced CRT modality, could offer superior patient outcomes compared to standard CRT in a specific subgroup: CRT-indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction, and LBBB. This research is significant for refining treatment strategies and optimizing device programming for heart failure patients.
Trial design
The Mid-Q Response study was a completed, prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study, designated as Phase NA. It enrolled a total of 177 participants across approximately 60 centers in Asia. The study focused on patients with conditions including Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II, and Heart Failure NYHA Class III. Participants were randomly assigned in a 1:1 ratio to either the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Control Group) to test the hypothesis that the AdaptivCRT algorithm is superior to standard CRT therapy regarding patient outcomes.
Key results
The study reported key measurements and analyses comparing the AdaptivCRT ON and AdaptivCRT OFF groups:
- Clinical Composite Score:
- In the AdaptivCRT ON group, participant counts were 66, 10, and 10.
- In the AdaptivCRT OFF group, participant counts were 68, 11, and 6.
- Change in New York Heart Association (NYHA) Class:
- In the AdaptivCRT ON group, participant counts were 1, 30, and 55.
- In the AdaptivCRT OFF group, participant counts were 1, 31, and 53.
Key statistical analyses did not demonstrate a statistically significant difference between the two groups:
- A Chi-squared analysis yielded a p-value of 0.61.
- A Logistic Regression analysis for an Odds Ratio (OR) resulted in a p-value of 0.63, with an OR of 1.192 (95.0% Confidence Interval: 0.579 to 2.455). This analysis grouped NYHA class III, IV, and death as a single category due to limited subject numbers.
- A Cox Regression analysis for a Hazard Ratio (HR) yielded a p-value of 0.64, with an HR of 1.25 (95.0% Confidence Interval: 0.492 to 3.175).
- A Log Rank analysis resulted in a p-value of 0.78.
- Another Cox Regression analysis for a Hazard Ratio (HR) yielded a p-value of 0.98, with an HR of 1.02 (95.0% Confidence Interval: 0.206 to 5.056).
What this means
The results of the Mid-Q Response study suggest that the AdaptivCRT algorithm did not demonstrate statistical superiority over standard CRT therapy for the evaluated patient outcomes. The consistently high p-values (ranging from 0.61 to 0.98) across various statistical analyses indicate that any observed differences between the AdaptivCRT ON and OFF groups were not statistically significant. This implies that for patients with heart failure, moderate QRS duration, preserved AV conduction, and left bundle branch block, the AdaptivCRT algorithm, as tested in this study, may not provide additional clinical benefit compared to standard CRT.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04180696, titled "Mid-Q Response Study", were posted on 2025-05-30 on clinicaltrials.gov.