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

Heart Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• ICD Therapy
• Tachycardia
• Thromboembolic Events
• Thromboembolism

• NCT number: NCT01774357
• Study type: Observational [Patient Registry]
• Source: Biotronik SE & Co. KG
• Status: Completed
• Start date: January 2013
• Completion date: September 19, 2018