NCT04118803

Observational Study on Inappropriate Therapies

Observational Study on Inappropriate Therapies After Replacement of ICDs

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 881 (actual)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)

Detailed description

All subjects will be included during an inclusion visit (within 7 days post generator replacement or upgrade), and followed up at a post replacement visit (1 - 6 months post replacement or upgrade), at 12, 18 and 24 months post replacement or upgrade. These follow-up visits will be performed in-clinic except for the 18 months post replacement or upgrade visit, which could be performed through device remote monitoring. Additional follow-ups can be performed at physician's discretion. Data on reportable adverse events will be collected throughout the study. All study data will be collected using an EDC system. All delivered anti-tachycardia therapies (shock or ATP) will be reviewed by an independent board of experts in order to evaluate appropriateness. The programming of the device parameters is at physician's discretion (suggested settings is slow VT monitoring zone 150 - 185 bpm with 30 cycles persistence, VT zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).

Conditions

• Inappropriate Shocks From Implanted Defibrillator
• ICD Replacement or Upgrade

Interventions

Type	Name	Description
DEVICE	ICD replacement or upgrade	Currently, it is common for patients to survive beyond their initial prophylactic ICD generator. It is unclear whether further benefit related to inappropriate shocks or ATP is derived from long-term device therapy, particularly if there has been a change in the patient's cardiovascular condition.

Timeline

• Start date: 2020-01-31
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2019-10-08
• Last updated: 2023-06-05

Locations

58 sites across 11 countries: United States, Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom