Trial reportJournal of cardiovascular electrophysiology2021
The extravascular implantable cardioverter-defibrillator: The pivotal study plan.
Trial report in Journal of cardiovascular electrophysiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed.
- Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study.Circulation · 2025Trial
- The extravascular implantable cardioverter-defibrillator: The pivotal study plan.Journal of cardiovascular electrophysiology · 2021Trial
- Safety and Efficacy of the Extravascular Implantable Cardioverter-Defibrillator (EV-ICD) in Japanese Patients: Final Results From the EV ICD Japan Study.Circulation reports · 2026Article
- Implantation of an extravascular implantable cardioverter-defibrillator in a patient with retrosternal adhesions from epicardial leads implanted via a subxiphoid approach.HeartRhythm case reports · 2026Article
- Mediastinal Air Entrapment During Extravascular ICD Implantation: A Preventable Cause of Elevated Shock Impedance.Journal of cardiovascular electrophysiology · 2026Article
- AI-Enabled Sensor Technologies for Remote Arrhythmic Monitoring in High-Risk Cardiomyopathy Genotypes.Sensors (Basel, Switzerland) · 2026Review
- Successful extravascular implantable cardioverter-defibrillator implantation in a patient with a preexisting transvenous dual-chamber pacemaker: A case report.HeartRhythm case reports · 2026Article
- Next-generation ICDs: Individualised Selection for Improved Cardiac Outcomes.Arrhythmia & electrophysiology review · 2026Review
- Review
- Successful implantation of an extravascular implantable cardioverter-defibrillator in a patient with moderate pectus excavatum: a case report.European heart journal. Case reports · 2025Article
- Successfully escaping the pleura with the extra-vascular implantable cardioverter defibrillator lead: a case report.European heart journal. Case reports · 2025Article
- First Human Implant With Cardiac Contractility Modulation in a Patient With an Extravascular Implantable Cardioverter-Defibrillator.JACC. Case reports · 2025Article
- Design of a post-market registry for the extravascular implantable cardioverter-defibrillator: The Enlighten Study.Heart rhythm O2 · 2025Article
- Clinical Decision Making and Technical Approaches in Implantable Cardioverter-Defibrillator Procedures: A Step by Step Critical Appraisal of Literature.Reviews in cardiovascular medicine · 2024Review
- [Practical guidance for the implantation of non-transvenous ICD systems].Herzschrittmachertherapie & Elektrophysiologie · 2024Article
- Recent Advancements in Bioelectronic Medicine: A Review.Current drug delivery · 2024Review
- Prevention of Cardiac Implantable Electronic Device Infections: A Review.Reviews in cardiovascular medicine · 2023Review
- Leadless Cardiac Pacing: New Horizons.Cardiology and therapy · 2023Review
- Quantifying Cardiothoracic Variation with Posture and Respiration to Inform Cardiac Device Design.Cardiovascular engineering and technology · 2023Article
- Practical considerations, indications, and future perspectives for leadless and extravascular cardiac implantable electronic devices: a position paper by EHRA/HRS/LAHRS/APHRS.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2022Article
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTransvenous implantable cardioverter defibrillators (TV ICD) provide life-saving therapy for millions of patients worldwide. However, they are susceptible to several potential short- and long- term complications including cardiac perforation and pneumothorax, lead dislodgement, venous obstruction, and infection. The extravascular ICD system's novel design and substernal implant approach avoids the risks associated with TV ICDs while still providing pacing features and similar generator size to TV ICDs. STUDY
designThe EV ICD pivotal study is a prospective, multicenter, single-arm, nonrandomized, premarket clinical study designed to examine the safety and acute efficacy of the system. This study will enroll up to 400 patients with a Class I or IIa indication for implantation of an ICD. Implanted subjects will be followed up to approximately 3.5 years, depending on when the patient is enrolled.
objectiveThe clinical trial is designed to demonstrate safety and effectiveness of the EV ICD system in human use. The safety endpoint is freedom from major complications, while the efficacy endpoint is defibrillation success. Both endpoints will be assessed against prespecified criteria. Additionally, this study will evaluate antitachycardia pacing performance, electrical performance, extracardiac pacing sensation, asystole pacing, appropriate and inappropriate shocks, as well as a summary of adverse events.
conclusionThe EV ICD pivotal study is designed to provide clear evidence addressing the safety and efficacy performance of the EV ICD System.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.