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

This study is currently recruiting participants.
Verified January 2013 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01774357
First received: January 21, 2013
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Atrial Fibrillation
Tachycardia
ICD Therapy
Thromboembolic Events
Heart Failure

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Frequency and types of AF-related complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to occurrence of first AF-related complication [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to AF-related intervention after detection of de novo or worsening AF [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and type of complications related to implantation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Frequency and type of lead-related complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Cardiovascular hospitalization with days in hospital [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Significance of AF in acute decompensation of heart failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Interventions based on Home Monitoring information regarding AF [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2013
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Detailed Description:

Enrollment / Pre-Discharge

Timing:

• At pre-hospital discharge 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)

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):

  • Demographic data
  • Etiology of underlying heart disease
  • Cardiac history, symptoms (NYHA classification)
  • AF history
  • Risk factors and co-morbidities
  • Vital signs
  • Current medication (substance class)
  • LVEF (echocardiography preferred, other methods accepted if no echo available; optional)
  • ECG parameters (12 lead ECG; optional)
  • History of thromboembolic events or stroke
  • Implantation

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):

  • Vital signs
  • Current medication (substance class)
  • LVEF (echocardiography preferred, other methods accepted if no echo available; optional)
  • ECG parameters (12 lead ECG; optional)

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774357

Contacts
Contact: Viola Hofer, Dr. +49 9131 8924 ext 7827 viola.hofer@biotronik.com
Contact: Stephanie Schonegg, Dr. +49 30 68905 ext 1317 stephanie.schonegg@biotronik.com

Locations
Germany
Heinrich-Braun-Klinikum Zwickau gemeinnützige GmbH Recruiting
Zwickau, Germany, 08060
Contact: Holger Sigusch, PD Dr.     +49 375 512219     holger.sigusch@hbk-zwickau.de    
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Gerhard Hindricks, Prof. Dr. Herzzentrum Leipzig, Germany
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01774357     History of Changes
Other Study ID Numbers: TA102
Study First Received: January 21, 2013
Last Updated: January 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Tachycardia
Thromboembolism
Embolism
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on June 18, 2013