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OpenTrials
Completed

NCT Number: NCT04767516

Multicenter Subcutaneous ICD Registry

This multicenter registry aims to collect data regarding S-ICD longevity, and battery and lead failure rates. Only clinically collected data is gathered in this registry.

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Key information

Conditions

ICD ICD Malfunction

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • S/P S-ICD Implantation

Exclusion criteria

  • n/a

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Generator Explantation

    Time frame: from baseline to incidence of explantation through study completion, an average of 5 year

    Incidence of S-ICD generator explantation, due to battery depletion, infection or system upgrade. Assessed by medical records and device interrogation.

  2. Lead Failure

    Time frame: from baseline to incidence of lead failure,through study completion, an average of 5 year

    Incidence of S-ICD lead failure. Assessed by medical records and device interrogation.

Secondary outcomes

  1. Battery Longevity

    Time frame: from baseline to incidence of battery depletion through study completion, an average of 5 year

    Incidence of regular battery depletion. Assessed by medical records and device interrogation.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Köln

Other

Collaborators

  • Children's Hospital Colorado
  • EVKLN Duisburg
  • La Fe Hospital Valencia
  • Med.Hochschule Hannover
  • St.Barts Hospital, London
  • Stanford Healthcare
  • Uniklinik Giessen
  • Uniklinik Ulm
  • University Hospital Southampton NHS Foundation Trust
  • University Hospital, Bordeaux
  • VCU Hospital, Richmond
  • Veterans Affairs Hospital San Juan

Registry information

Official study title

Multicenter Registry of Subcutaneous ICD Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2021
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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