Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-01 @ 3:10 PM
Study NCT ID:
NCT01774357
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2013-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATRIX
Brief 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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: