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Implantable Cardioverter Defibrillator
Extravascular Defibrillation for Ventricular Arrhythmia (EV ICD Trial)
N/A
Waitlist Available
Led By Paul Friedman, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimated to be 9 months
Awards & highlights
EV ICD Trial Summary
This trial is to show that the EV ICD System is safe and effective.
Who is the study for?
This trial is for adults who need an Implantable Cardioverter Defibrillator (ICD) as per heart health guidelines, are stable enough to follow the study plan, and can consent. It's not for those with certain past surgeries or conditions affecting the chest area, oxygen-dependent lung disease, severe liver enlargement, or women who are pregnant/breastfeeding without birth control.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of a new Extravascular ICD System designed to correct life-threatening rapid heartbeats. Participants will receive this device and be monitored to see how well it works compared to traditional methods.See study design
What are the potential side effects?
Potential side effects may include discomfort at implant site, infection risk from surgery, inappropriate shocks if the device misreads heart rhythm, bleeding due to temporary stopping of blood thinners during implantation.
EV ICD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, estimated to be 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimated to be 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 6 Months Post-implant
Secondary outcome measures
Continued Access Measure
EV ICD Trial Design
1Treatment groups
Experimental Treatment
Group I: Implant AttemptExperimental Treatment1 Intervention
Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defibrillation using the Extravascular ICD
2019
N/A
~390
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Who is running the clinical trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
198 Previous Clinical Trials
128,574 Total Patients Enrolled
8 Trials studying Ventricular Arrhythmia
5,962 Patients Enrolled for Ventricular Arrhythmia
Paul Friedman, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
1,000,550 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had surgery in the upper abdomen before.You are scheduled to have a sternotomy.You have a hiatal hernia that changes the way your chest area looks.You need to use oxygen because of your COPD.The patient has a noticeably enlarged liver and spleen.You have a medical condition that prevents you from having a defibrillator test.You have had a medical condition or procedure that caused scarring in the space in front of your heart.You received radiation treatment to your chest in the past.You have a specific heart condition that requires an implantable cardioverter-defibrillator (ICD) according to heart health guidelines.You have a heart condition that requires a pacemaker or Cardiac Resynchronization Therapy.You have a pacemaker, ICD, or CRT device implanted in your body.You have had a previous surgery called sternotomy.You have a significant chest bone abnormality, such as pectus excavatum.You have severe heart failure.You currently have an infection or are receiving treatment for an infection.You currently have a device implanted in your body that delivers electrical current.You meet specific medical guidelines that suggest you have a very short life expectancy.You have a medical need for an implantable cardioverter defibrillator (ICD) based on specific heart health guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Implant Attempt
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.
Is there a possibility of participating in this research project at present?
"Presently, this clinical trial is actively recruiting patients. The initial post date was September 16th 2019 and the page has been recently updated on November 29th 2022 according to data available on clinicialtrials.gov."
Answered by AI
In what capacity has this trial been implemented in various medical settings?
"Currently, 4 sites are signing up individuals for this trial. These include Jacksonville, Washington and Kansas City in addition to other nearby locations. To reduce travel costs associated with participation, it is best to select the closest location available."
Answered by AI
To what extent are patients participating in this clinical trial?
"Medtronic Cardiac Rhythm and Heart failure are in need of 556 participants that meet the entry criteria to conduct this trial. Participating locations include Continued Access: Baptist Health in Jacksonville, Florida, and Continued Access: Medstar Washington Hospital Center in Washington D.C.."
Answered by AI
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