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Device Therapy

CRT Optimization for Heart Failure

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
Non-responder (ejection fraction improvement with CRT < 5%) or incomplete responder (ejection fraction < 40%)
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

Study Summary

This trial is studying how well cardiac resynchronization therapy (CRT) works when the device is programmed according to information from a standard electrocardiogram (ECG).

Who is the study for?
This trial is for adults over 18 with heart failure who have a CRT device but haven't seen much improvement. They should be on standard therapy, have had the device for more than 4 months, and show suboptimal heart rhythm patterns on an ECG. People can't join if they're in acute heart failure, pregnant or breastfeeding, allergic to certain ECG or MRI materials, have specific types of pacing leads or irregular heartbeat issues.Check my eligibility
What is being tested?
The study tests how adjusting the settings of a CRT device might help patients who don't respond well to initial treatment. It uses cardiac MR imaging to see the effects of these adjustments both right away and over time.See study design
What are the potential side effects?
Since this trial involves programming changes rather than drugs, side effects are minimal but may include discomfort from wearing ECG electrodes or reactions to MRI contrast agents like gadolinium if one is allergic.

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 hasn't improved much or remains low after treatment.
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I am older than 18 years.
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I have had a CRT device for more than 4 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute changes in left ventricular end-diastolic volume in study population
Acute changes in left ventricular end-systolic volume in study population
Acute changes in left ventricular mechanical synchrony in study population
+5 more
Secondary outcome measures
Change in 6 Minute Hall Walk (6MHW)
Change in Kansis City Cardiomyopathy Questionnaire (KCCQ)
Other outcome measures
Correlation in electrical dyssynchrony and left ventricular function in study population

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Electrocardiography-guided optimal CRT programmingExperimental Treatment1 Intervention
The experimental arm patients will have CRT device programmed based on the electrocardiographic assessment for 12 months.
Group II: Baseline CRT programmingActive Control1 Intervention
The comparator arm patients will remain at baseline CRT programming for the first 6 months, and then will crossover to the experimental arm and CRT device will be programmed to optimal settings derived from the electrocardiographic assessment for the following 6 months.

Find a Location

Who is running the clinical trial?

Minneapolis Heart Institute FoundationOTHER
29 Previous Clinical Trials
15,425 Total Patients Enrolled
Allina Health SystemLead Sponsor
57 Previous Clinical Trials
1,177,174 Total Patients Enrolled
5 Trials studying Heart Failure
3,240 Patients Enrolled for Heart Failure
Alan J Bank, MDPrincipal InvestigatorAllina Heath System
4 Previous Clinical Trials
989 Total Patients Enrolled
4 Trials studying Heart Failure
989 Patients Enrolled for Heart Failure

Media Library

Programming of CRT device settings (Device Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04763460 — N/A
Heart Failure Research Study Groups: Baseline CRT programming, Electrocardiography-guided optimal CRT programming
Heart Failure Clinical Trial 2023: Programming of CRT device settings Highlights & Side Effects. Trial Name: NCT04763460 — N/A
Programming of CRT device settings (Device Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763460 — N/A
~10 spots leftby Jun 2025
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