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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
CSPOT Trial Summary
This trial will compare three different types of cardiac resynchronization therapy to see which is the most effective and safe.
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.Check my eligibility
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.See study design
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.
CSPOT Trial 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.
Select...
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.
CSPOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrical synchronization response
Hemodynamic response
Secondary outcome measures
Clinical Composite Score (CCS)
Left ventricular ejection fraction (LVEF)
Left ventricular end systolic volume (LVESV)
CSPOT 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
Find a Location
Who is running the clinical trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
198 Previous Clinical Trials
128,870 Total Patients Enrolled
78 Trials studying Heart Failure
65,773 Patients Enrolled for Heart Failure
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots remaining in this trial?
"Affirmative. The information on clinicaltrials.gov indicates that this research endeavour is still recruiting patients, having first gone live on November 27th 2021 and most recently updated on December 7th of the same year. 60 participants are being sought after at one specific facility."
Answered by AI
How many individuals are eligible to join this clinical research?
"Affirmative. Information found on clinicaltrials.gov attests to the fact that this scientific trial, which was posted in November of 2021, is presently enrolling participants. Specifically, 60 individuals are needed from a single medical centre."
Answered by AI
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