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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 belowSelect...
My heart's pumping ability hasn't improved much or remains low after treatment.
Select...
I am older than 18 years.
Select...
I have had a CRT device for more than 4 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
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 moreSecondary 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
56 Previous Clinical Trials
1,175,174 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical signals are not working well with the current settings of the device.I am currently receiving standard treatment for my condition.My heart's pumping ability hasn't improved much or remains low after treatment.You have a heart condition with frequent abnormal heartbeats.My heart is unable to pump blood effectively.I am older than 18 years.I have had a CRT device for more than 4 months.You have a specific type of heart condition that affects the electrical signals in your heart.I have a pacemaker lead in my heart's His or left bundle branch.My heart often beats faster than 100 beats per minute.You have had serious allergic reactions to ECG gels, electrode adhesives, or cardiac magnetic resonance contrast.You have a specific heart condition called "right bundle branch block."
Research Study Groups:
This trial has the following groups:- Group 1: Baseline CRT programming
- Group 2: Electrocardiography-guided optimal CRT programming
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this clinical trial still open to new participants?
"Affirmative. Clinicaltrials.gov confirms that this experiment is still seeking volunteers, which it initially posted on July 1st 2021 and updated lastly on September 21st 2021. Ultimately, 40 people are needed from 2 distinct sites to complete the trial."
Answered by AI
What qualifications must potential participants of this experiment meet?
"Participation in this clinical trial requires that the patient is suffering from systolic heart failure and must fall between 18-100 years of age. Currently, 40 individuals are being considered for inclusion."
Answered by AI
Are the age restrictions for participation in this experiment limited to those 25 and under?
"This clinical trial stipulates that participants need to be between 18 and 100 years old, as dictated by the entry criteria."
Answered by AI
How many participants are enrolled in the current experiment?
"Affirmative. The trial's listing on clinicaltrials.gov reveals that enrolment is ongoing for this research project, which initially became available to the public on July 1st 2021; it was last edited 21 September 2021. Forty volunteers are required from two distinct centres."
Answered by AI
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