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OpenTrials
Completed

NCT Number: NCT04869527

Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.

To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.

Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.

Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).

Completed

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Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Santa Casa de Misericórdia de Porto Alegre - Brugada Institute, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.

Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.

Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).

Primary Endpoint:

  • First confirmed episode of AF or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to the HMSC.

Other events of interest:

  • Rate of successful transmissions received and stored on the HMSC platform;
  • Hospital admissions related to cardiologic outcomes, at any time throughout the FU period;
  • A composite outcome of any of the following device-related complications: Need for any lead repositioning or replacement, pneumothorax, new pericardial effusion, tamponade, procedure-related death or wound infection, within 60 days after the ICD insertion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for implanting of a single chamber ICD (primary or secondary prevention) according to current guidelines;
  • Sustained sinus rhythm as the current prevalent atrial rhythm;
  • Planned de novo implantation with a BIOTRONIK single chamber DX ICD system;
  • Patient is able to understand the nature of study and to provide written informed consent;
  • Patient is willing and able to perform all follow up visits at the study site;
  • Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion criteria

  • Age < 18 years
  • Any limitation to contractual capability;
  • Female patients who are pregnant or breast feeding or planning pregnancy during the course of the study;
  • Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment;
  • Life expectancy < 2 years;
  • Patient is participating in any other interventional clinical investigation.

Treatment and study plan

BIOTRONIK ICDs with DX Technology

Device

The BIOTRONIK DX system offers a single chamber ICD that enables sensing of atrial signals through floating atrial dipoles, using a single ventricular lead. This technology enables enhanced arrhythmia diagnosis based on atrial and ventricular electrograms and, in addition, early diagnosis and automatic transmission of AF and heart failure (HF) diagnostic data. The DX technology provides several features in a single chamber device that are usually only found in dual chamber devices, including atrial diagnostics and SVT discrimination - early detection of SAF, increased diagnostics accuracy, dual-chamber discrimination. Nevertheless, the benefits of a single chamber device are preserved: reduced lead complications, reduced procedure complexity, elimination of costs for atrial lead. The DX system also integrates with BIOTRONIK Home Monitoring, allowing physicians to remotely follow their patients' clinical and device statuses with daily updates.

Primary outcomes

  1. New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes

    Time frame: 12 months

    All patients enrolled presented with sinus rhythm, confirmed also during the implant. Outcome was considered positive with the occurence of first confirmed episode of Atrial Fibrillation (AF) or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to BIOTRONIK's Home Monitoring Service Center (HMSC), lasting at least 30 seconds to be considered relevant. The adjudication was carried out by the independent investigator in charge of the remote monitoring.

Secondary outcomes

  1. Successful Remote Monitoring Data Transmission to BIOTRONIK's HMSC Platform

    Time frame: 12 months

    All patients enrolled received a remote monitoring unit (BIOTRONIK's CARDIOMESSENGER SMART) providing automatic telemetry (read only) for data gathering and encrypted transmission to BIOTRONIK's Home Monitoring Service Center (HMSC). This outcome represents the percentage of days with successful Home Monitoring transmissions after the first recorded transmission. The Home Monitoring system automatically sends encrypted data through the mobile network to the BIOTRONIK Home Monitoring Service Center (HMSC), using cellular telephone network for data transmission.

  2. Cardiologic Hospitalization

    Time frame: 12 months

    Number of patients with at least one hospitalization related to cardiologic outcomes during the follow-up period.

  3. Device Related Complication

    Time frame: 60 days

    A composite outcome of any of the following device-related complications: Number of patients who need for any lead repositioning or replacement, pneumothorax, new pericardial effusion, tamponade, procedure-related death, or wound infection, within 60 days after the ICD insertion.

Other outcomes

  1. Cumulative Incidence of Primary Endpoint at 90 Days

    Time frame: 90 days

    Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed.

  2. Cumulative Incidence of First AF/AFL/SVT Episode at 90 Days

    Time frame: 90 days

    Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed.

  3. Cumulative Incidence of First AF/AFL/SVT Episode at 180 Days

    Time frame: 180 days

    Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 180 days. No hypothesis testing was performed.

  4. Cumulative Incidence of First AF/AFL/SVT Episode at 360 Days

    Time frame: 360 days

    Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 360 days. No hypothesis testing was performed.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

Registry information

Official study title

Simplifying Access to Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Continuous Home Monitoring in Brazil

Acronym: SAFE-DX-Home

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 3, 2021
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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