NCT07360158

Brief Summary

The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock\_BC (Ilivia Neo, Intica Neo) implant and programmer software features. The new features of CorSky Family are either true novel BIOTRONIK ICD features or mainly driven by unification with the Amvia pacemaker family (Amvia Edge, -Sky). The goal of the study is to confirm the safety and performance of the CorSky Family of ICDs and CRT-Ds.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 6, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 14, 2026

Last Update Submit

March 5, 2026

Conditions

TachyarrhythmiaHeart Failure

Outcome Measures

Primary Outcomes (1)

  • CorSky-related SADE-d free rate at 6 months

    6 months

Interventions

CorSky ICD or CRT-DDEVICE

Subjects with an indication for an ICD or CRT-D device will be implanted with a CorSky device of the CorSky ICD family according to standard implantation procedures. Device programming will be done according to the medical needs of the subjects.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Standard indication for ICD or CRT-D

You may qualify if:

  • Standard indication for ICD or CRT-D therapy according to clinical guidelines
  • Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker
  • Ability to understand the nature of the study.
  • Ability and willingness to perform all on-site follow-up visits at the study site.
  • Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept.

You may not qualify if:

  • For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia
  • For VR-T DX and CRT-DX: Patients requiring atrial pacing
  • Planned for His-Bundle-Pacing
  • Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
  • Pregnant or breast feeding.
  • Age less than 18 years.
  • Participation in an interventional clinical investigation in parallel to this study. ,
  • Life-expectancy less than 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

TachycardiaHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-01