Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy

AMEND-CRT: Better Selection for Heart Failure Device Therapy

NCT: NCT04225520 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: Universitaire Ziekenhuizen KU Leuven · Started: 2020-12-10 · Est. Completion: 2030-12-01

Plain English Summary

AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT is a Not Applicable clinical trial sponsored by Universitaire Ziekenhuizen KU Leuven studying Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated, Cardiac Remodeling, Ventricular. This trial tests if a new way to measure heart movement can help decide which patients with heart failure should receive a special pacemaker called CRT. It is for patients with heart failure and a weakened left ventricle who meet specific criteria. Participation involves receiving a CRT device, and then randomly being assigned to have the device's pacing turned on or off based on the new measurement. Current methods for selecting patients for CRT have a high failure rate, meaning many patients don't benefit and face risks. The trial aims to enroll 500 participants.

Official Summary

Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with a weakened left ventricle (ejection fraction of 35% or less) and enlarged heart chamber. Patients must have stable heart condition for at least a month and have had blocked arteries treated if present. Individuals with certain heart valve problems, severe lung issues not related to heart failure, or those on dialysis will not be eligible. People with a life expectancy of less than one year, or who are pregnant or breastfeeding, cannot join. This trial is studying Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated, Cardiac Remodeling, Ventricular, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see if the new method of measuring heart movement leads to similar or better heart function and overall health compared to current methods, while implanting fewer unnecessary devic The specific primary outcome measures are: Volume response and Packer Clinical Composite Score (12 months follow-up). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to improve the selection of patients for cardiac resynchronization therapy (CRT) by using a new measurement of heart movement, potentially reducing unnecessary treatments and improving This research targets Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated, Cardiac Remodeling, Ventricular, where improved treatment options are needed.

Investor Insight

This trial addresses a significant unmet need in heart failure management, aiming to reduce the 30-40% non-responder rate for CRT, which represents a substantial market opportunity for improved device

Is This Trial Right for Me?

Ask your doctor if your heart's electrical activity and mechanical movement are out of sync. Understand that you will receive a CRT device, and then it will be determined if its pacing feature is turned on or off based on your specific heart's mechanical properties. This trial involves regular follow-up appointments for about a year to monitor your heart's response. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04225520?

NCT04225520 is a Not Applicable INTERVENTIONAL study titled "AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT." It is currently active, not recruiting and is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial targets enrollment of 500 participants.

What conditions does NCT04225520 study?

This trial investigates treatments for Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated, Cardiac Remodeling, Ventricular. The primary condition under study is Left Ventricular Dyssynchrony.

What treatments are being tested in NCT04225520?

The interventions being studied include: Cardiac resynchronization therapy ON (DEVICE), Cardiac resynchronization therapy OFF (DEVICE). Implantation of a CRT device. Bi-ventricular pacing will be turned ON.

What does Not Applicable mean for NCT04225520?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT04225520?

This trial is currently "Active, Not Recruiting." It started on 2020-12-10. The estimated completion date is 2030-12-01.

Who is sponsoring NCT04225520?

NCT04225520 is sponsored by Universitaire Ziekenhuizen KU Leuven. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04225520?

The trial aims to enroll 500 participants. The trial status is active, not recruiting.

How is NCT04225520 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT04225520?

The primary outcome measures are: Volume response and Packer Clinical Composite Score (12 months follow-up). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04225520 being conducted?

This trial is being conducted at 20 sites, including Antwerp; Bruges; Ghent; Leuven and 16 more sites (Belgium, Brazil, France).

Where can I find official information about NCT04225520?

The official record for NCT04225520 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04225520. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04225520 testing in simple terms?

This trial tests if a new way to measure heart movement can help decide which patients with heart failure should receive a special pacemaker called CRT. It is for patients with heart failure and a weakened left ventricle who meet specific criteria.

Why is this trial significant?

This trial aims to improve the selection of patients for cardiac resynchronization therapy (CRT) by using a new measurement of heart movement, potentially reducing unnecessary treatments and improving

What are the potential risks of participating in NCT04225520?

As with any device implantation, there are risks of infection, bleeding, or device malfunction. Potential side effects of CRT therapy itself can include worsening heart failure symptoms, irregular heartbeats, or discomfort. The new selection method might incorrectly identify patients who would or would not benefit from CRT. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04225520?

Ask your doctor if your heart's electrical activity and mechanical movement are out of sync. Understand that you will receive a CRT device, and then it will be determined if its pacing feature is turned on or off based on your specific heart's mechanical properties. This trial involves regular follow-up appointments for about a year to monitor your heart's response. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04225520 signal from an investment perspective?

This trial addresses a significant unmet need in heart failure management, aiming to reduce the 30-40% non-responder rate for CRT, which represents a substantial market opportunity for improved device This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves receiving a CRT device, and then randomly being assigned to have the device's pacing turned on or off based on the new measurement. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.