This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months. All analyses on the data will be done post-hoc; the study does not intend to confirm any pre-specified hypotheses.

Enrollment (E0)

Timing:

• The enrollment (date of patient written informed consent) starts after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system according to current guidelines (primary or secondary prevention) but should not be later than 90 days after implantation.

Procedures:

• Check inclusion and exclusion criteria
• Patient information and written informed consent process
• Assignment of a unique study code
• ICD interrogation (re-programming if necessary)
• HMSC registration (recommended)
• Investigator assessment: appropriate atrial sensing

Documentation (note: where available the most recent assessment recorded within six months prior to hospital discharge shall be considered):

• Medical History:

  • Demographic data
  • General history of cardiovascular disease
  • Etiology of underlying heart disease
  • Cardiac events and symptoms
  • Documented supraventricular arrhythmia prior to implantation

• Device Interrogation

  • Date, home monitoring function, MRI scan

• AF history:

  • type (none, paroxysmal, persistent, permanent)
  • date of first diagnosis (if applicable)
  • EHRA classification (if applicable)
  • AF burden (if available)
  • CHA2DS2-VASc
  • Risk factors and comorbidities:
  • thyroid dysfunction
  • diabetes mellitus
  • COPD
  • sleep apnea
  • chronic renal disease
  • History of thromboembolic events or stroke

• Physical Examination:

  • Vital signs (SBP, DBP, height, body weight, BMI)
  • Current medication (substance class)
  • Heart failure indices
  • NYHA classification
  • BNP and NT-proBNP (only if determined in routine clinical practice)
  • LVEF (optional; echocardiography preferred, other methods accepted if no echo available)
  • ECG parameters (12 lead ECG; optional)
  • RR, PQ, and QT intervals
  • QRS width
  • rhythm disorders
  • clinical findings, morphology

• Implantation:

  • Indication (primary prevention, secondary prevention)
  • Type of procedure (first implantation / replacement)
  • RV lead:
  • Dislodgement / repositioning after implantation?
  • Sufficient amplitudes (Atrial; Ventricular) and thresholds (Ventricular)
  • Other clinical complications during / after implantation?
  • Final lead position at discharge (apical, septal, other)
  • Atrial dipole (with or without atrial wall contact at rest)
  • Ease of implantation as assessed by investigator
  • An extended questionnaire including more detailed information on implantation procedure, technique and initial measurements will be requested as an optional documentation where data are available

Follow-up Y1 and Y2

Timing:

• 12 and 24 months (+/-2 months) after enrollment respectively

Procedures:

• ICD interrogation / function check-up and re-programming if necessary
• Programmer download of all data not yet submitted to BIOTRONIK according to current working instruction
• Investigator assessment: appropriate atrial sensing

Documentation (note: where available the most recent assessment recorded between the current and the preceding visit shall be considered):

• Physical Examination:

  • Vital signs (SBP, DBP, height, body weight, BMI)
  • Current medication (substance class)
  • Heart Failure indices:
  • NYHA classification
  • BNP and NT-proBNP (only if determined in routine clinical practice)
  • LVEF (optional; echocardiography preferred, other methods accepted if no echo available)
  • ECG parameters (12 lead ECG; optional):
  • RR, PQ, and QT intervals
  • QRS width
  • rhythm disorders
  • clinical findings, morphology

• Device Interrogation

  • Date, home monitoring function, MRI scan

Event based documentation

• New-onset or worsening AF
• AF interventions
• Worsening heart failure
• Shock episode
• Thromboembolic events (CVA, TIA, PAE)
• Continuous surveillance / reporting of (serious) adverse events / (serious) adverse device effects

Inclusion Criteria:

• Indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines
• Implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment
• Written informed consent, willingness and ability to comply with the protocol

Exclusion Criteria:

• Age < 18 years
• Any limitation to contractual capability
• Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
• Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment
• Simultaneous participation in another study
• Life expectancy < 2 years

Patients with an indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines and after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment