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Left Bundle Branch Area Pacing for Heart Failure Non-Responders to Cardiac Resynchronization Therapy

N/A
Recruiting
Led By Selma D Carlson, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All Veterans in this study will have undergone CRT at least 12 months prior to enrollment and determined to have non-response by all the following criteria: Lack of improvement in New York Heart Association (NYHA) class, Lack of LVEF increase by > 5%, Lack of decrease in LVESV by > 15%
Must not have
Known cancer patients, actively receiving chemotherapy
Patients with high risk of procedure-related infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if placing a new electrode in a different part of the heart may improve heart function & reduce heart failure symptoms in patients who haven't improved after cardiac resynchronization therapy.

Who is the study for?
This trial is for veterans with heart failure who didn't get better after cardiac resynchronization therapy (CRT) at least a year ago. They should not have improved in symptoms, heart pumping function, or heart size reduction. It's not for those with weak immune systems, cancer patients on chemo, pregnant women, or anyone unable to follow the study plan.
What is being tested?
The study tests if placing a new pacing lead in a different part of the heart can help people whose hearts haven't responded to CRT. Participants will undergo an MRI and receive left bundle branch area pacing to see if it improves their heart function and reduces symptoms.
What are the potential side effects?
Possible side effects include discomfort from the new pacemaker placement procedure, risks associated with undergoing an MRI like claustrophobia or reactions to metal implants, and potential infection risk from the surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a veteran who didn't improve after heart therapy over a year ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently undergoing chemotherapy for cancer.
Select...
I am at high risk for infections from medical procedures.
Select...
I am able to understand and give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Left ventricular ejection fraction by echocardiography
Secondary study objectives
Interventricular mechanical delay measurement by 2D speckle-tracking echocardiography
Left ventricular ejection fraction by cardiac MRI

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
Group I: LBBAPExperimental Treatment1 Intervention
This arm will investigate improvement in cardiac function following placement of the LBBA pacing electrode in half the patients.
Group II: Cardiac MRI with devicesExperimental Treatment1 Intervention
This arm will investigate the feasibility of cardiac MRI to be used to measure cardiac function in patients with cardiac devices.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac MRI
2017
Completed Phase 4
~3210

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,842 Total Patients Enrolled
39 Trials studying Heart Failure
63,291 Patients Enrolled for Heart Failure
Selma D Carlson, MDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN

Media Library

LBBAP Clinical Trial Eligibility Overview. Trial Name: NCT05884411 — N/A
Heart Failure Research Study Groups: LBBAP, Cardiac MRI with devices
Heart Failure Clinical Trial 2023: LBBAP Highlights & Side Effects. Trial Name: NCT05884411 — N/A
LBBAP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05884411 — N/A
~16 spots leftby Mar 2028
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