CSPOT for Heart Failure

(CSPOT Trial)

Recruiting at 11 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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing three different methods to help patients with irregular heartbeats. It uses special devices to send electrical signals that make the heart beat more regularly. The goal is to find out which method works best and is safest.

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.

Is CSPOT for Heart Failure generally safe for humans?

Research on similar pacing therapies shows that while there are benefits, there are also risks like lead dislodgement and the need for reintervention. Some patients experienced complications, but new designs are improving safety and feasibility. ^{1 2 3 4 5}

How is the CSPOT treatment for heart failure different from other treatments?

Conduction System Pacing Optimized Therapy (CSPOT) is unique because it focuses on pacing the heart's natural conduction system, which can lead to more natural heartbeats compared to traditional methods that pace the heart from the outside. This approach may improve heart function and synchronization more effectively than conventional cardiac resynchronization therapy (CRT), especially in patients with heart failure. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment CSPOT for Heart Failure?

Research shows that conduction system pacing (CSP) can improve heart function in patients with heart failure by enhancing electrical synchronization in the heart. Studies found that CSP improved heart pumping efficiency and reduced symptoms compared to traditional pacing methods. ^{6 9 10 11 12}

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. United States pubmed.ncbi.nlm.nih.gov

Improved outcomes of conduction system pacing in heart failure with reduced ejection fraction: A systematic review and meta-analysis. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The feasibility and safety of his-purkinje conduction system pacing in patients with heart failure with severely reduced ejection fraction. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of conduction system pacing for cardiac resynchronization therapy in patients with heart failure: A multicenter experience. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

How to deliver personalized cardiac resynchronization therapy through the precise measurement of the acute hemodynamic response: Insights from the iSpot trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The evolution of cardiac resynchronization therapy and an introduction to conduction system pacing: a conceptual review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Haemodynamic Alterations Induced By Cardiac Pacing: Is Clinical Evaluation Sufficient Or Do We Need Long-Term Device Monitoring? [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Conduction system pacing in prosthetic heart valves. [2023]

8. France pubmed.ncbi.nlm.nih.gov

[Resynchronization of the failing heart by pacing]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Acute hemodynamic effects of single- and dual-site left ventricular pacing employing a dual cathodal coronary sinus lead. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transvenous biventricular pacing for heart failure: can the obstacles be overcome? [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes in Conduction System Pacing Compared to Right Ventricular Pacing in Bradycardia. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Effect of scar and His-Purkinje and myocardium conduction on response to conduction system pacing. [2023]