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Device Therapy
CRT Optimization for Heart Failure (METEOR-CRT Trial)
N/A
Recruiting
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
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 belowSelect...
My heart's pumping ability is 40% or less before treatment.
Select...
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
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
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
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.
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Who is running the clinical trial?
Allina Health SystemLead Sponsor
57 Previous Clinical Trials
1,177,053 Total Patients Enrolled
5 Trials studying Heart Failure
3,160 Patients Enrolled for Heart Failure
Alan J Bank, MDPrincipal InvestigatorUnited Heart & Vascular - Allina Health System
4 Previous Clinical Trials
909 Total Patients Enrolled
4 Trials studying Heart Failure
909 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am getting or have recently received a CRT device for the first time.I am on the best medication regimen for my condition.You have clear heart images for measuring how well your heart is pumping and the size of your heart's chambers.You had a bad allergic reaction to the gel or adhesives used for ECG tests in the past.My heart's pumping ability is 40% or less before treatment.You have a heart condition with a high number of premature ventricular contractions.I am 18 years old or older.You have a specific heart condition called right bundle branch block (RBBB).The patient has a special type of pacing lead called a His Bundle pacing lead.
Research Study Groups:
This trial has the following groups:- Group 1: Standard CRT Programming, then ECG CRT Optimization
- Group 2: ECG CRT Optimization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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