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

NCT ID: NCT01774357

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2054 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-09-19

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

Conditions

Atrial Fibrillation; Tachycardia; ICD Therapy; Thromboembolic Events; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Hindricks, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Leipzig, Germany

Locations

Herzzentrum Leipzig

Leipzig, Saxony, Germany

Countries

Germany

Other Identifiers

TA102

Identifier Type: -

Identifier Source: org_study_id