Trial Outcomes & Findings for ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study (NCT NCT07091916)

NCT ID: NCT07091916

Last Updated: 2025-09-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 2 weeks (14 days) post-implant
• Results posted on: 2025-09-03

Participant Flow

The first site was activated on 20JAN2023. The first EV ICD Japan subject was enrolled on 22FEB2023 and implanted on 01 MAR 2023. The last subject enrollment occurred on 27SEP2023, and the last implant occurred on 03OCT2023. Sites were notified of enrollment completion on 01DEC2023.

Participant milestones

Measure	Implant Attempt Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study

Baseline characteristics by cohort

Measure	Implant Attempt EV ICD Japan n=14 Participants Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
Age, Continuous	53.6 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks (14 days) post-implant

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.

Outcome measures

Measure	Implant Attempt n=14 Participants Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant	13 Participants

PRIMARY outcome

Timeframe: At Implant

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.

Outcome measures

Measure	Implant Attempt n=14 Participants Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System	14 Participants

Adverse Events

Enrolled Japan Study

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enrolled Japan Study n=14 participants at risk Subjects enrolled in the Extravascular ICD Japan Study
Injury, poisoning and procedural complications Incision site pain	21.4% 3/14 • Number of events 3 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Cardiac disorders Cardiac perforation	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Product Issues Device inversion	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Injury, poisoning and procedural complications Procedural pain	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0

Other adverse events

Measure	Enrolled Japan Study n=14 participants at risk Subjects enrolled in the Extravascular ICD Japan Study
General disorders Inflammation	14.3% 2/14 • Number of events 2 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Psychiatric disorders Insomnia	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Injury, poisoning and procedural complications Incision site pain	21.4% 3/14 • Number of events 3 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Cardiac disorders Ventricular tachycardia	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Respiratory, thoracic and mediastinal disorders Sputum retention	14.3% 2/14 • Number of events 2 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Gastrointestinal disorders Chronic gastritis	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Gastrointestinal disorders Gastrooesophageal reflux disease	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Gastrointestinal disorders Hiatus hernia	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
General disorders Medical device site pain	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Infections and infestations Coronavirus infection	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Infections and infestations Nasopharyngitis	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Infections and infestations Renal cyst infection	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Joint neoplasm	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Product Issues Device pacing issue	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Skin and subcutaneous tissue disorders Dermatitis contact	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0
Skin and subcutaneous tissue disorders Rash	7.1% 1/14 • Number of events 1 • Among the 14 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 112.9 ± 59.9 days. All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 26.0

Additional Information

Takuto Yamamoto

Medtronic Japan Co., Ltd.

Phone: +818046716498

Email: takuto.yamamoto@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place