60 Participants Needed

CSPOT for Heart Failure

(CSPOT Trial)

Recruiting at 11 trial locations
RR
JA
JA
JM
Overseen ByJessica Mikacevich
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.69101112

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.
See 2 more

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.
See 13 more

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?
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials
206
Recruited
137,000+
Geoff Martha profile image

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson profile image

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

Citations

Improved outcomes of conduction system pacing in heart failure with reduced ejection fraction: A systematic review and meta-analysis. [2023]
The feasibility and safety of his-purkinje conduction system pacing in patients with heart failure with severely reduced ejection fraction. [2023]
Outcomes of conduction system pacing for cardiac resynchronization therapy in patients with heart failure: A multicenter experience. [2023]
How to deliver personalized cardiac resynchronization therapy through the precise measurement of the acute hemodynamic response: Insights from the iSpot trial. [2023]
The evolution of cardiac resynchronization therapy and an introduction to conduction system pacing: a conceptual review. [2022]
Haemodynamic Alterations Induced By Cardiac Pacing: Is Clinical Evaluation Sufficient Or Do We Need Long-Term Device Monitoring? [2022]
Conduction system pacing in prosthetic heart valves. [2023]
[Resynchronization of the failing heart by pacing]. [2019]
Acute hemodynamic effects of single- and dual-site left ventricular pacing employing a dual cathodal coronary sinus lead. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Transvenous biventricular pacing for heart failure: can the obstacles be overcome? [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Clinical Outcomes in Conduction System Pacing Compared to Right Ventricular Pacing in Bradycardia. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Effect of scar and His-Purkinje and myocardium conduction on response to conduction system pacing. [2023]
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