What side effects are associated with this type of intervention?

The most common treatments for ventricular arrhythmia include implantable cardioverter-defibrillators (ICDs) and antiarrhythmic medications. ICDs, like the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System, detect and correct abnormal heart rhythms by delivering electrical shocks. Known side effects of ICDs include infection at the implant site, lead dislodgement, inappropriate shocks, and psychological impacts such as anxiety. Antiarrhythmic medications can cause side effects like dizziness, fatigue, gastrointestinal issues, and in some cases, proarrhythmia, which is the aggravation of existing arrhythmias or the creation of new ones.

What prior FDA approvals exist?

The FDA has approved several treatments for ventricular arrhythmia, particularly focusing on implantable devices that deliver electrical shocks to correct abnormal heart rhythms. Notable among these are traditional Implantable Cardioverter Defibrillators (ICDs), which have been widely used to prevent sudden cardiac death by detecting and treating life-threatening arrhythmias. Additionally, antiarrhythmic drugs such as amiodarone and sotalol have been approved to manage ventricular arrhythmias, although they work through pharmacological means rather than electrical shocks. The Extravascular Implantable Cardioverter Defibrillator (EV ICD) System represents an advancement in this field, offering a less invasive option for delivering life-saving electrical therapy.

What other types of research exist?

Promising novel alternatives to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System for ventricular arrhythmia patients in 2024 include: 1) Subcutaneous ICDs (S-ICDs), which are less invasive and avoid transvenous leads, reducing infection risks. 2) Leadless pacemakers, which are entirely self-contained within the heart, eliminating the need for leads and reducing complications. 3) Cardiac contractility modulation (CCM) devices, which improve heart contractility and may benefit patients with heart failure and arrhythmias. 4) Advanced ablation techniques using high-precision mapping and robotic assistance to target arrhythmogenic tissue more effectively. These alternatives offer various benefits and should be discussed with a healthcare provider to determine the best option based on individual patient needs and conditions.

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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

No Placebo-Only Group

Summary

This trial tests a new defibrillator that places wires outside the heart and veins. It is for patients who need a device to manage dangerous heart rhythms. The device monitors the heart and delivers electric shocks to correct serious rhythm problems.

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimated to be 9 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

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 study objectives

Continued Access Measure

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Implant AttemptExperimental Treatment1 Intervention

Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.

Group II: Continued Access Implant AttemptExperimental Treatment1 Intervention

Continued Access for United States

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Defibrillation using the Extravascular ICD

2019

N/A

~420

Do I qualify?Apply below to find out

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

The Extravascular Implantable Cardioverter Defibrillator (EV ICD) System detects abnormal heart rhythms and corrects them by delivering electrical shocks, which is essential for preventing sudden cardiac death in patients with Ventricular Arrhythmia. This system is implanted outside the heart and vasculature, reducing the risks associated with traditional transvenous ICDs. Other common treatments include antiarrhythmic drugs, which stabilize the heart's electrical activity, and catheter ablation, which destroys the tissue causing the arrhythmia. These treatments are vital for managing Ventricular Arrhythmia, as they help maintain a stable heart rhythm and prevent life-threatening complications.