management and detection of atrial tachyarrhythmias in patients implanted with biotronik dx systems

Conditions: Atrial Fibrillation; Tachycardia; ICD Therapy; Thromboembolic Events; Heart Failure

Summary: 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

Eligibility criteria:
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