Wearable Cardioverter-Defibrillator (WCD) Registry II in Europe

Wearable Cardioverter-Defibrillator (WCD) Registry II in Europe - WEARIT II Europe

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005653

Enrollment

900

Registered

2014-01-16

Start date

2014-01-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart conditions leading to a high risk of sudden arrhythmic death (SCD) I21 Z95.1 I42 I50 R55 U55.10 I45.8 T82.7 U55.11 U55.12

Interventions

Group 1: Observational study (no intervention): ventricular arrhythmic events recorded by the wearable cardioverter-defibrillator (WCD) will be documented and assessed by the treating physician

the patient answers questionnaires with regard to use of the WCD after end of wearing the WCD and after 1 year after start of wearing the WCD.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients to whom the wearable cardioverter-defibrillator (WCD) will be prescribed during clinical routine 1. for risk assessment prior to ICD implantation or prior to deferring ICD implantation; 2. for protection until a new ICD can be implanted in cases where the original ICD had been removed

Exclusion criteria

Exclusion criteria: Patients who will be unable (physically or mentally) to handle and use the WCD device appropriately

Design outcomes

Primary

Measure	Time frame
1. prospectively evaluate a) the incidence of life-threatening ventricular tachyarrhythmic events, b) the success of cardioversion/defibrillation by the wearable cardioverter-defibrillator (WCD) and c) the short-term outcome and clinical development (i.e. improvement of left ventricular function or reduction of heart failure symptoms) of patients during the time of wearing the WCD (Phase I of the Registry). 2. evaluate the 1-year outcome of patients after they have started to use the WCD, the clinical status and the clinical correctness of decision-making based on information from phase I (Phase II of the Registry)	—

Measure

Time frame

1. prospectively evaluate a) the incidence of life-threatening ventricular tachyarrhythmic events, b) the success of cardioversion/defibrillation by the wearable cardioverter-defibrillator (WCD) and c) the short-term outcome and clinical development (i.e. improvement of left ventricular function or reduction of heart failure symptoms) of patients during the time of wearing the WCD (Phase I of the Registry). 2. evaluate the 1-year outcome of patients after they have started to use the WCD, the clinical status and the clinical correctness of decision-making based on information from phase I (Phase II of the Registry)

—

Secondary

Measure	Time frame
• Evaluate the clinical outcome (death, hospitalization, medical interventions) after end of wearing time of wearable cardioverter-defibrillator (WCD) and after 1 year; • Evaluate the development of left ventricular ejection fraction (LV-EF) after end of wearing time of WCD and after 1 year in patients with structural heart disease.	—

Countries

Germany

Contacts

Public ContactHelmut Klein

helmut.klein@heart.rochester.edu+49-89-51563724

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026