What side effects are associated with this type of intervention?

Cardiac Resynchronization Therapy (CRT) is a common treatment for heart failure that involves the use of a specialized pacemaker to improve the heart's rhythm and function. Known side effects of CRT include infection at the implantation site, lead dislodgement, and device malfunction. Other potential side effects are related to the surgical procedure itself, such as bleeding, bruising, and pain at the site of implantation. Additionally, some patients may experience arrhythmias or heart rhythm disturbances post-implantation.

What prior FDA approvals exist?

Cardiac Resynchronization Therapy (CRT) is an FDA-approved treatment for heart failure patients with reduced left ventricular ejection fraction and electrical dyssynchrony. CRT involves the use of a device that provides biventricular pacing to improve the heart's efficiency and coordination. This therapy has been shown to enhance quality of life, exercise capacity, and reduce hospitalization rates and mortality. Additionally, CRT devices often include an implantable cardioverter-defibrillator (ICD) for patients who meet specific criteria, providing both resynchronization and protection against sudden cardiac death.

What other types of research exist?

Promising novel alternatives to Cardiac Resynchronization Therapy (CRT) for heart failure patients in 2024 include: 1) His bundle pacing, which directly stimulates the His-Purkinje conduction system to achieve more natural ventricular activation and synchronization. 2) Left bundle branch area pacing, which targets the left bundle branch to improve electrical synchronization. 3) Adaptive pacing algorithms in advanced pacemakers that dynamically adjust pacing parameters based on real-time cardiac function. 4) Multi-point pacing, which uses multiple pacing sites within the left ventricle to enhance resynchronization. These alternatives aim to optimize cardiac function and improve patient outcomes by providing more physiologically appropriate pacing strategies.

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Device Therapy

CRT Optimization for Heart Failure (METEOR-CRT Trial)

N/A

Waitlist Available

Led By Alan J Bank, MD

Research Sponsored by Allina Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-CRT EF less than or equal 40%

Age greater than or equal 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a heart device that helps the heart beat more regularly by using information from heart activity tests. It targets heart failure patients with specific heart issues who often do not respond well to typical treatments. The device works by sending electrical pulses to the heart and adjusting these pulses based on detailed heart activity readings.

Who is the study for?

This trial is for adults over 18 with heart failure who are getting or have recently received their first CRT device and have a left ventricular ejection fraction of 40% or less. They must be on the best medication regimen, able to give informed consent, and not part of another study that could affect results.

What is being tested?

The study aims to optimize cardiac resynchronization therapy (CRT) in new recipients by adjusting the device settings based on standard ECG readings. It seeks to improve heart function and quality of life in patients who often don't respond well to current CRT setups.

What are the potential side effects?

While this trial focuses on reprogramming existing devices rather than testing new drugs, potential side effects may include discomfort from ECG procedures or skin reactions from electrode adhesives.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is 40% or less before treatment.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in left ventricular function

Change in left ventricular size

Other study objectives

Correlation of change in electrical dyssynchrony and LVESV

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ECG CRT OptimizationExperimental Treatment1 Intervention

The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.

Group II: Standard CRT Programming, then ECG CRT OptimizationActive Control1 Intervention

The control arm patients will have standard CRT programming for the first 6 months, and then will be reprogrammed based on the ECG CRT optimization information for the following 6 months

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cardiac Resynchronization Therapy (CRT) is a key treatment for heart failure patients with reduced left ventricular ejection fraction and electrical dyssynchrony. CRT works by using a device to synchronize the contractions of the left and right ventricles, improving the efficiency of the heart's pumping action. This is achieved through the implantation of pacing leads in the right atrium, right ventricle, and a coronary vein overlying the left ventricle. By restoring synchronized ventricular contractions, CRT can enhance cardiac output, reduce symptoms, and improve quality of life. This is particularly important for heart failure patients as it can decrease hospitalization rates and mortality, addressing the detrimental effects of ventricular dyssynchrony on cardiac function.