CSPOT for Heart Failure

(CSPOT Trial)

No longer recruiting at 12 trial locations

Overseen By Jessica Mikacevich

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Must not be taking: Inotropic therapy

Disqualifiers: Atrial fibrillation, AV block, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to deliver cardiac resynchronization therapy (CRT) for people with heart failure. It compares various heart pacing methods, including traditional approaches and new methods like Conduction System Pacing Optimized Therapy (CSPOT) configuration, to determine which is most effective and safe. The trial suits individuals needing a new CRT device, particularly those without left bundle branch block, a specific heart rhythm issue.

As an unphased study, this trial provides a unique opportunity for patients to contribute to innovative research in heart failure treatment.

Do I need to stop my current medications for the CSPOT trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on continuous infusion therapy for heart failure, you may not be eligible to participate.

What prior data suggests that these pacing configurations are safe for heart failure patients?

Studies have shown that conduction system pacing (CSP) can be safe and effective. CSP is often used for individuals with heart conditions such as heart failure. Research indicates that patients with CSP can experience improved heart function and require fewer hospital visits compared to traditional methods.

In one study, patients with CSP experienced positive heart health outcomes, and the treatment was generally well-tolerated, meaning most did not encounter serious problems. However, like any medical procedure, some side effects can occur, including minor issues related to the device placement.

Overall, CSP, including the CSPOT setup, appears to be a promising and safe option for heart patients. It is important to discuss the risks and benefits with a doctor if considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Conduction System Pacing Optimized Therapy (CSPOT) for heart failure because it offers a new approach to pacing the heart. Unlike traditional cardiac resynchronization therapy (CRT) that uses generic pacing settings, CSPOT customizes the pacing to each patient's unique cardiac conduction system. This personalized method aims to enhance heart function more effectively by optimizing the timing of electrical impulses, potentially leading to better outcomes and fewer side effects. Additionally, CSPOT may improve the heart's pumping efficiency by focusing on the natural conduction pathways, which could make a significant difference in managing heart failure.

What evidence suggests that this trial's pacing configurations could be effective for heart failure?

Research shows that conduction system pacing (CSP) can be a promising option for heart failure patients. Studies have found that CSP may lower the risk of death or hospital visits due to heart failure compared to traditional biventricular pacing. Specifically, CSP was linked to fewer of these events, with rates of 28.3% compared to 38.4% for biventricular pacing. CSP also helps the heart beat more in sync, which is important for heart failure patients with reduced heart function. In this trial, all participants will undergo the CSPOT approach, which combines CSP with left ventricular pacing to enhance these benefits further. Overall, early results suggest CSPOT could improve heart function and reduce complications. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who need a new or upgraded CRT device and can follow the study plan. They should have specific types of irregular heartbeats but not persistent AF/AFL, severe valve issues, recent heart attacks, or certain other conditions.

Inclusion Criteria

I am willing and able to follow the study's requirements.

I am willing and able to sign a consent form.

My medical records can be accessed by the trial site during the study.

Exclusion Criteria

I have a complex heart condition from birth that hasn't been corrected.

You have 2nd or 3rd degree AV (Atrioventricular) Block.

I have severe hardening of my heart's main artery or severe artery disease in my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implantation and Acute Pacing Protocol

Participants undergo CSPOT lead placement, acute pacing protocol with various configurations, and device implantation

At implant

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Conduction system pacing-only configuration
• Conduction System Pacing Optimized Therapy (CSPOT) configuration
• Left ventricular coronary sinus configuration

Trial Overview The study compares three ways to pace the heart in people with heart failure: traditional biventricular pacing, conduction system pacing-only, and CSPOT which combines both methods. It aims to find out which is best for different patient groups.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 3 Interventions

Patients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months.

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials

206

Recruited

137,000+

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10353285/

Conduction System Pacing for Cardiac Resynchronization ... Cardiac resynchronization therapy (CRT) is an established therapy for medically refractory heart failure (HF), with a reduction in ...

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)00207-8/abstract

Conduction system pacing versus biventricular ... Conduction system pacing (CSP) has emerged as a promising alternative to biventricular pacing (BVP) in patients with heart failure with reduced ejection ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8076975/

Conduction System Pacing for Cardiac Resynchronisation There is an emerging role for CSP to achieve cardiac resynchronisation in patients with heart failure with reduced ejection fraction and inter-ventricular ...

4. hrsonline.org hrsonline.org/news/hr22-latest-advances-conduction-system-pacing/

Heart Rhythm 2022 Reveals Latest Advances in ... CSP was associated with significant reduction in the combined endpoint of time to death or heart failure hospitalization (28.3% vs 38.4%; HR ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X25001872

Clinical Response to Resynchronization Therapy ... Garre, et al. Conduction system pacing vs biventricular pacing in heart failure and wide QRS patients. JACC Clin Electrophysiol, 8 (11) (2022), pp. 1431-1445.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10225322/

Outcomes of Conduction System Pacing for Cardiac ... Among the CRT responders in the CSP group, 45 (62%) patients had CRT device implantation due to cardiomyopathy with a LVEF ≤35% and wide bundle branch block ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772632023000302

Systematic Review Conduction system pacing vs. ... Our analysis showed better ECG, ECHO, and clinical outcomes in terms of mortality and HHF with CSP compared to BVP.

8. ctv.veeva.com ctv.veeva.com/study/conduction-system-pacing-optimized-therapy

Conduction System Pacing Optimized Therapy (CSPOT) The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients.

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013059

Multicenter Hemodynamic Assessment of the LOT-CRT ... In a CRT cohort with advanced conduction disease, LOT-CRT and BVP provided greater acute hemodynamic benefit than LBBAP.

10. jacc.org jacc.org/doi/10.1016/j.jacep.2023.06.005

Cardiac Conduction System Pacing: A Comprehensive ... Left bundle branch block (LBBB) results in delayed and dyssynchronous activation of the LV, which is deleterious in patients with heart failure. BVP improves ...