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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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am a veteran who didn't improve after heart therapy over a year ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Left ventricular ejection fraction by echocardiography

Secondary outcome measures

Interventricular mechanical delay measurement by 2D speckle-tracking echocardiography

Left ventricular ejection fraction by cardiac MRI

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

~3280

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,260 Total Patients Enrolled

38 Trials studying Heart Failure

63,164 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for the experiment still open?

"This medical study is still actively seeking participants, as the latest information from clinicaltrials.gov shows it was last edited on May 22nd 2023 after being initially posted on April 30th of that same year."

Answered by AI

How many participants will this clinical trial comprise?

"Affirmative. As per the information available on clinicaltrials.gov, this medical exploration is presently recruiting trial subjects. It was first released on April 30th 2023 and last updated on May 22nd 2023; it seeks 24 participants from a single facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response

2023. "Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05884411.