AI-Guided Pacing for Heart Failure

Overseen By Sean Olson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Age less than 18, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Approximately 1-2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well an AI-assisted pacing method for the heart, specifically AI-assisted Left Bundle Branch Area Pacing, compares to the usual method in helping people with heart failure. The researchers aim to determine if AI can improve heart function and overall health outcomes. Participants may qualify if they have heart failure with a specific heart function measurement (less than 50% efficiency) and are on standard heart failure treatments. As an unphased trial, this study offers a unique opportunity to contribute to cutting-edge research that could enhance future heart failure treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you are already on optimized medical therapy for heart failure.

What prior data suggests that AI-assisted Left Bundle Branch Area Pacing is safe for heart failure patients?

Research has shown that Left Bundle Branch Area Pacing (LBBAP) is a relatively safe treatment for heart issues. Studies indicate that LBBAP offers advantages over other pacing methods, particularly for patients with heart failure. However, there is a 12% risk of developing pacing-induced cardiomyopathy, a heart muscle disease caused by pacing. This risk necessitates careful selection of candidates for this treatment.

The AI-assisted version of LBBAP under testing aims to enhance its effectiveness. Although specific safety data for the AI-guided method is not yet available, traditional LBBAP is generally well-tolerated. Prospective trial participants may find this information helpful in understanding the potential safety of the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AI-assisted Left Bundle Branch Area Pacing for heart failure because it introduces artificial intelligence to improve the precision of pacemaker placements. Unlike traditional pacemakers, which rely on fixed settings, this AI-guided approach can dynamically adjust pacing based on real-time data from the patient's heart, potentially improving heart function and patient outcomes. This innovative use of AI could lead to more personalized treatment strategies, offering hope for enhanced quality of life for those with heart failure.

What evidence suggests that AI-assisted Left Bundle Branch Area Pacing is effective for heart failure?

This trial will compare AI-assisted Left Bundle Branch Area Pacing (LBBAP) with a control treatment for heart failure. Research has shown that AI assistance with LBBAP could benefit people with heart failure. AI-guided pacing uses artificial intelligence to adjust heart stimulation. Studies have found that LBBAP can lower the risk of worsening heart failure and reduce the chance of death by better coordinating heartbeats. AI guidance might enhance these benefits by fine-tuning the pacing. Early results suggest this method can improve heart function and quality of life for heart failure patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Fatima Ezzeddine

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure, where the heart's pumping strength (LVEF) is below 50%. They must have a specific ECG pattern or expect to need significant pacemaker use. Participants should be on stable heart medications but not pregnant or unable to attend follow-up appointments.

Inclusion Criteria

Left Ventricular Ejection Fraction (LVEF): Less than 50% within 6 months prior to enrollment

QRS Duration: Resting QRS duration is greater than or equal to 130 ms on ECG OR anticipated right ventricular pacing is greater than 40% OR device in place with right ventricular pacing is greater than 40% within 6 months prior to enrollment

AI-ECG probability of low LVEF is greater than 0.5

Exclusion Criteria

Pregnancy

I cannot commit to regular check-ups.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo AI-guided or conventional LBBAP procedure

Approximately 1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for CRT response and clinical outcomes

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• AI-assisted Left Bundle Branch Area Pacing

Trial Overview

The study compares traditional Left Bundle Branch Area Pacing (LBBAP) with an AI-assisted version for improving treatment response and health outcomes in patients needing cardiac resynchronization therapy.

How Is the Trial Designed?

Group I: AI-guided Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07206602

NCT07206602 | AI-Guided Left Bundle Branch Area Pacing

... outcomes. Correction: Shown ... Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure.

2.

academic.oup.com

academic.oup.com/europace/article/27/8/euaf181/8242754

Two-year outcomes of left bundle branch area pacing versus ...

Prolonged right ventricular pacing (RVP) increases the risk of cardiomyopathy, atrial fibrillation, heart failure (HF), and mortality.

3.

ctv.veeva.com

ctv.veeva.com/study/ai-guided-left-bundle-branch-area-pacing

AI-Guided Left Bundle Branch Area Pacing

Medical Therapy: Optimized on guideline-directed medical therapy for heart failure. AI-ECG probability of low LVEF: >0.5. Exclusion Criteria.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38227817/

Using artificial intelligence-enabled electrocardiogram to ...

... outcomes of left bundle branch area ... Cardiac resynchronization therapy; Electrocardiogram; Heart failure; Left bundle branch area pacing.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2214027125000624

First demonstration of left bundle branch area pacemaker ...

Cardiac physiologic pacing has been found to reduce progression to heart failure and death. The LBBAP approach, has demonstrated multiple ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666501825002077

Efficacy and safety of left bundle branch pacing compared ...

1, 2, 3 A meta-analysis by Somma et al found a 12% incidence of pacing-induced cardiomyopathy (PICM), highlighting the importance of selecting an optimal pacing ...

7.

jacc.org

jacc.org/doi/10.1016/j.jacep.2020.08.015

Left Bundle Branch Area Pacing for Cardiac ...

CRT using biventricular pacing is effective in patients with heart failure and left bundle branch block (LBBB). LBBAP has been reported as an ...