Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
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