臨床研究等提出・公開システム

ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study

EV ICD Japan Study

Yamamoto Takuto

Medtronic Japan

Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo

takuto.yamamoto@medtronic.com

Yamamoto Takuto

Medtronic Japan

Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo

+81-80-4671-6498

takuto.yamamoto@medtronic.com

Not Recruiting

June. 24, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines, or ESC guidelines.
2. Patient is at least 18 years of age and meets age requirements per local law.
3. Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.

1. Patient is unwilling or unable to personally provide Informed Consent.
2. Patient has indications for bradycardia pacing or Cardiac Resynchronization Therapy (CRT) (Class I, IIa, or IIb indication).
3. Patients with an existing pacemaker, ICD, or CRT device implant or leads.
4. Patients with these medical interventions are excluded from participation in the study:
- Prior sternotomy
- Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis)
- Prior abdominal surgery in the epigastric region
- Planned sternotomy
- Prior chest radiotherapy
Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
5. Patient has previous pericarditis that:
- Was chronic and recurrent, or
- Resulted in pericardial effusion, or
- Resulted in pericardial thickening or calcification.
6. Patients with these medical conditions or anatomies are excluded from participation in the study:
- Hiatal hernia that distorts mediastinal anatomy
- Marked sternal abnormality (e.g., pectus excavatum)
- Decompensated heart failure
- COPD with oxygen dependence
- Gross hepatosplenomegaly
Or any other known medical condition or anatomy type not listed that precludes their participation in the opinion of the Investigator.
7. Patients with a medical condition that precludes them from undergoing defibrillation testing:
- Severe aortic stenosis
- Intracardiac LA or LV thro
- Severe proximal three-vessel or left main coronary artery disease without revascularization
- Hemodynamic instability
- Unstable angina
- Recent stroke or transient ischemic attack (within the last 6 months)
- Known inadequate external defibrillation
- LVEF < 20%
- LVEDD >70 mm
Or any other known medical condition not listed that precludes their participation in the opinion of the Investigator.
8. Patient with any evidence of active infection or undergoing treatment for an infection
9. Patient is contraindicated from temporary suspension of oral/systemic anticoagulation
10. Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body.
11. Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 month).
12. Patient is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
13. Patient with any exclusion criteria as required by local law (e.g., age or other).
14. Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.

Both

Developing, life-threatening ventricular tachyarrhythmias

Treatment using the MDT-1120 system

1. Characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant.
2. Characterize the EV ICD defibrillation testing success rate at implant.

- Characterize appropriate and inappropriate shocks
- Characterize electrical performance (pacing capture thresholds, pacing impedance, sensing amplitudes) over time
- Characterize extracardiac pacing sensation
- Characterize asystole pacing
- Summarize ATP performance with spontaneous arrhythmias
- Summarize adverse events
- Characterize EV ICD defibrillation testing conducted per physician discretion

+81-3-5269-7839

June. 13, 2022

No

none