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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01774357
First received: January 21, 2013
Last updated: May 23, 2016
Last verified: May 2016
  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:


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 ]

Enrollment: 2058
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Herzzentrum Leipzig
Leipzig, Sachsen, Germany, 04289
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Gerhard Hindricks, Prof. Dr. Herzzentrum Leipzig, Germany
  More Information

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: May 23, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 25, 2016