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

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.

Study Overview

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

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 2054

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Leipzig, Sachsen, Germany, 04289
      • Herzzentrum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with an indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines and after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Gerhard Hindricks, Prof. Dr., Herzzentrum Leipzig, Germany

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 19, 2018

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Atrial Fibrillation; Tachycardia; Thromboembolism
• Other Study ID Numbers: TA102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO