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