Ventricular arrhythmia, Ventricular fibrillation
Conditions
Interventions
Experimental Group (Phase 1):None
Experimental Group (Phase 2):MRI scan
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Meeting the Chinese expert consensus indications for ICD implantation; 2. First-time implantation of the investigational device; 3. Able and willing to undergo a non-indicated MRI examination without sedation; 4.Age >= 18 years; 5. Willing to participate in the trial and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of other cardiac rhythm management devices, components, or accessories, or non-MR compatible implants in the body; 2. Diagnosis of severe tricuspid valve disease or implantation of a mechanical prosthetic tricuspid valve; 3. Known or suspected allergy to dexamethasone sodium phosphate; 4. Planned cardiothoracic surgery or recipient of a heart transplantation during the follow-up period; 5. Planned MRI examinations for diagnostic or therapeutic purposes during the follow-up period, aside from the study-required MRI; 6. Life expectancy of less than 12 months; 7. Concurrent participation in other investigational drug or device clinical trials; 8. Females who are planning pregnancy, are pregnant, or are lactating; 9. Deemed by the investigator as unsuitable for participation in this trial (e.g., poor compliance, claustrophobia, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complications Associated with the INVICTA Defibrillation Lead;VT/VF termination success rate;Complications related to MRI procedures;Ventricular pacing threshold stability rate;Ventricular sensing threshold stability rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| INVICTA implantation success rate;Adverse Event Rate;Device Deficiency Rate;Electrical performance evaluation;VT/VF termination success rate after MRI scan;Adverse Event Rate after MRI scan;Device Deficiency Rate after MRI scan; | — |
Countries
China
Contacts
Public ContactYunlong Xia
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed