What side effects are associated with this type of intervention?

Treatments for heart failure similar to those studied in the CSPOT trial, such as cardiac resynchronization therapy (CRT) and pacing, can have side effects including infection at the implantation site, lead dislodgement, and device malfunction. Pacing-related complications may include inappropriate shocks, exacerbation of heart failure symptoms, and the development of arrhythmias. Monitoring for arterial stiffness and changes in blood pressure is also important.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that involve cardiac resynchronization therapy (CRT). Traditional biventricular (BiV) pacing has been a standard approach, with devices like the Medtronic InSync pacemaker being among the early approved systems. These devices aim to improve the coordination of the heart's contractions by pacing both the left and right ventricles. More recently, advancements have included conduction system pacing (CSP), which targets the heart's natural conduction pathways to achieve more physiological pacing. The CSPOT study is exploring the combination of CSP and LV pacing, which represents an evolution in CRT aimed at optimizing cardiac function in heart failure patients.

What other types of research exist?

Promising, novel alternatives to CSPOT for heart failure patients include wireless left ventricular (LV) stimulation, His-bundle pacing, and multisite pacing. These approaches aim to improve CRT response and overcome challenges associated with traditional LV lead implantation.

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Device

CSPOT for Heart Failure (CSPOT Trial)

N/A

Waitlist Available

Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is willing and able to comply with the protocol, including follow-up visits

Subject is at least 18 years of age

Must not have

Subject has complex and uncorrected congenital heart disease

Subject has severe aortic calcification or severe peripheral arterial disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include discomfort at the implant site, infection risk from surgery, potential lead displacement or malfunction of the device affecting heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I am getting a new CRT device or upgrading from a pacemaker or ICD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have severe narrowing of my heart's aortic valve.

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I have severe kidney disease.

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I am not pregnant or breastfeeding, and if capable of becoming pregnant, I use reliable birth control or practice abstinence.

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I have ongoing or permanent irregular heartbeats.

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I have had a heart transplant or am on the waiting list for one.

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I am receiving continuous heart failure medication through an infusion.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Electrical synchronization response

Hemodynamic response

Secondary study objectives

Clinical Composite Score (CCS)

Left ventricular ejection fraction (LVEF)

Left ventricular end systolic volume (LVESV)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment3 Interventions

On the date of implant, subjects will undergo Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then Conduction System Pacing Optimized Therapy (CSPOT) acute pacing protocol, and then device implant. During the acute pacing protocol, all subjects will undergo three types of pacing configurations (defined in the intervention descriptions), and will serve as their own control. The subject will then be implanted with the cardiac resynchronization therapy defibrillator (CRT-D) or cardiac resynchronization therapy pacemaker (CRT-P) device will be implanted. Each subject's device will be programmed to conduction system pacing optimized therapy (CSPOT) configuration. Subjects will be followed for 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Left ventricular coronary sinus configuration

2021

N/A

~60

Conduction system pacing-only configuration

2021

N/A

~60

Conduction System Pacing Optimized Therapy (CSPOT) configuration

2021

N/A

~60

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Heart failure treatments often include pharmacological therapies and device-based interventions. In the context of the CSPOT trial, which studies the combination of conduction system pacing (CSP) and left ventricular (LV) pacing, the focus is on optimizing cardiac resynchronization therapy (CRT). CSP aims to directly stimulate the heart's conduction system, leading to more physiologic and synchronized heart contractions. LV pacing, on the other hand, targets the left ventricle to improve its function and coordination with the right ventricle. This combination can enhance cardiac efficiency, reduce symptoms, and improve quality of life for heart failure patients by addressing the dyssynchrony that often exacerbates heart failure symptoms.

Problems and pitfalls in evaluating studies for pacing in heart failure.