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

Heart Failure Clinical Trial

— MATRIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774357
• Other study ID #: TA102
• Status: Completed
• Start date: January 2013
• Est. completion date: September 19, 2018

Study information

• Verified date: September 2018
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2054
• Est. completion date: September 19, 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Herzzentrum Leipzig	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and types of AF-related complications		24 months
Primary	Time to occurrence of first AF-related complication		24 months
Primary	Time to AF-related intervention after detection of de novo or worsening AF		24 months
Secondary	Frequency and type of complications related to implantation		24 months
Secondary	Frequency and type of lead-related complications		24 months
Secondary	All-cause mortality		24 months
Secondary	Cardiovascular hospitalization with days in hospital		24 months
Secondary	Significance of AF in acute decompensation of heart failure		24 months
Secondary	Interventions based on Home Monitoring information regarding AF		24 months