Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, tachycardia, icd therapy, thromboembolic events, heart failure
Sponsor Biotronik SE & Co. KG
Start date January 2013
End date July 2018
Trial size 2058 participants
Trial identifier NCT01774357, TA102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Frequency and types of AF-related complications
time frame: 24 months
Time to occurrence of first AF-related complication
time frame: 24 months
Time to AF-related intervention after detection of de novo or worsening AF
time frame: 24 months

Secondary Outcomes

Measure
Frequency and type of complications related to implantation
time frame: 24 months
Frequency and type of lead-related complications
time frame: 24 months
All-cause mortality
time frame: 24 months
Cardiovascular hospitalization with days in hospital
time frame: 24 months
Significance of AF in acute decompensation of heart failure
time frame: 24 months
Interventions based on Home Monitoring information regarding AF
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
Principal investigator Gerhard Hindricks, Prof. Dr.
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biotronik SE & Co. KG.