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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 belowSelect...
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:Select...
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
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
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.
Problems and pitfalls in evaluating studies for pacing in heart failure.
Find a Location
Who is running the clinical trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
202 Previous Clinical Trials
135,952 Total Patients Enrolled
80 Trials studying Heart Failure
71,775 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a complex heart condition from birth that hasn't been corrected.You have 2nd or 3rd degree AV (Atrioventricular) Block.I am willing and able to follow the study's requirements.I have severe hardening of my heart's main artery or severe artery disease in my legs.I am 18 years old or older.I have severe narrowing of my heart's aortic valve.You have a specific type of heart condition called right bundle branch block with no other related issues.I had valve surgery within the last 3 months.You have a surgically implanted device to help your heart pump blood.Your heart's QRS width is less than or equal to 120 milliseconds without using a pacemaker.I am willing and able to sign a consent form.I have severe kidney disease.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I use reliable birth control or practice abstinence.My medical records can be accessed by the trial site during the study.I am getting a new CRT device or upgrading from a pacemaker or ICD.You have a mechanical heart valve.I am eligible for a specific heart device due to my heart's rhythm issues, not primarily caused by LBBB.I have ongoing or permanent irregular heartbeats.I have had a heart transplant or am on the waiting list for one.I am receiving continuous heart failure medication through an infusion.I had a heart attack less than 40 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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