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ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
NA trial testing Defibrillation using the Extravascular ICD in Tachycardia in 14 participants. Completed in 23 January 2025.
| Lead sponsor | Medtronic Cardiac Rhythm and Heart Failure |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 14 |
| Start date | 22 February 2023 |
| Primary completion | 16 November 2023 |
| Estimated completion | 23 January 2025 |
| Sites | 1 location across Japan |
Medtronic Cardiac Rhythm and Heart Failure — full company profile →
18 and older, any sex, with Tachycardia or Ventricular Arrythmia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.
| Group | Value | 95% CI |
|---|---|---|
| Implant Attempt | 13 |
Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 6 such episodes may be induced to test device efficacy.
| Group | Value | 95% CI |
|---|---|---|
| Implant Attempt | 14 |
Time frame: Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Enrolled Japan Study |
|---|---|---|
| Incision site pain | Injury, poisoning and procedural complications | — |
| Cardiac perforation | Cardiac disorders | — |
| Device inversion | Product Issues | — |
| Procedural pain | Injury, poisoning and procedural complications | — |
| Reaction | System | Enrolled Japan Study |
|---|---|---|
| Incision site pain | Injury, poisoning and procedural complications | — |
| Inflammation | General disorders | — |
| Sputum retention | Respiratory, thoracic and mediastinal disorders | — |
| Insomnia | Psychiatric disorders | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Chronic gastritis | Gastrointestinal disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Hiatus hernia | Gastrointestinal disorders | — |
| Medical device site pain | General disorders | — |
| Coronavirus infection | Infections and infestations | — |
| Nasopharyngitis | Infections and infestations | — |
| Renal cyst infection | Infections and infestations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Joint neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Device pacing issue | Product Issues | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Incision site pain, Cardiac perforation, Device inversion, Procedural pain.
Data from ClinicalTrials.gov NCT07091916 adverse events section.
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing