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

NCT01774357 | Completed

• 1 other identifier: TA102
• Study Type: observational
• Target: 2,054
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Frequency and types of AF-related complications

  24 months

• Time to occurrence of first AF-related complication

  24 months

• Time to AF-related intervention after detection of de novo or worsening AF

  24 months

Secondary Outcomes (6)

• Frequency and type of complications related to implantation

  24 months

• Frequency and type of lead-related complications

  24 months

• All-cause mortality

  24 months

• Cardiovascular hospitalization with days in hospital

  24 months

• Significance of AF in acute decompensation of heart failure

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (1)

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia; Thromboembolism; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Gerhard Hindricks, Prof. Dr.

  Herzzentrum Leipzig, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 19, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)