AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 8, 2020

Keywords

ClinConnect Summary

The AMEND-CRT clinical trial is studying how to better select patients for a treatment called cardiac resynchronization therapy (CRT), which is used for people with certain heart conditions, including heart failure and left ventricular dyssynchrony. The goal is to determine if assessing a specific measurement called mechanical dyssynchrony (how well the heart's chambers work together) can help doctors identify who will benefit the most from CRT. Currently, many patients who receive this treatment don't see improvement, which can lead to unnecessary procedures. This trial aims to lower that number by using mechanical dyssynchrony as a key factor in deciding treatment options.

To be eligible for the trial, participants must be at least 18 years old, have a weakened heart function (with an ejection fraction of 35% or less), and have stable health for at least a month before joining. They will be randomly assigned to one of two groups: one will receive treatment based on standard guidelines, while the other will be treated based on the presence of mechanical dyssynchrony. All participants will receive CRT implantation, but the pacing settings may vary depending on their group. Over the course of a year, researchers will monitor their heart function and overall health to see which method leads to better outcomes. This trial is currently recruiting participants, and it’s important for potential candidates to understand the inclusion criteria and what to expect from their involvement.

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Eligibility criteria

• • (- - - - - - - - - Inclusion Criteria - - - - - - - - -)
• The proposed inclusion criteria represent the minimum recommendations for CRT implantation in heart failure patients according to the ESC 2021 guidelines. In addition:
• • Patient has a LVEF ≤ 35%
• • Patient has a LVEDD ≥ 2.7cm/m² or LVEDD ≥ 50mm (m) and ≥45mm (f)
• • Patient has been in a stable medical condition for ≥ 1 month prior inclusion
• • Patient underwent complete revascularization in case of ischemia
• • Patients is able to understand and willing to provide a written informed consent
• • Patient is 18 years or older
• • (- - - - - - - - - Exclusion Criteria - - - - - - - - -)
• Patients with the following conditions will be excluded:
• • unreliable left ventricular volume measurements
• • severe MR or more than moderate other valvular disease
• • pulmonary hypertension, other than secondary to left heart disease
• • patient on hemodialysis
• • life expectancy \< 1 year
• • pregnant or breastfeeding
• • Patients with prior right ventricular pacing between 20% to 80% will be excluded.
• Patients with prior right ventricular pacing ≤ 20% or no pacemaker / ICD will be excluded if they have any of the following criteria:
• • PR duration \> 250ms
• • second / third degree atrioventricular block
• • intrinsic QRS duration \< 130ms
• • atrial fibrillation with resting HR \< 50/min or \> 80/min
• Patients with prior right ventricular pacing ≥ 80% will be excluded if they have any of the following criteria:
• • sensed AV delay \> 250ms
• • paced AV delay \> 280ms
• • Patients with a prior pacemaker / ICD scheduled for LBBaP will be excluded regardless of pacing percentage