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

June 12, 2026 updated by: Biotronik SE & Co. KG

Simplifying Access to Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Continuous 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01533-000
        • BIOTRONIK Coml Médica LTDA
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients requiring an ICD implant

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Cardiologic Hospitalization
Time Frame: 12 months
Number of patients with at least one hospitalization related to cardiologic outcomes during the follow-up period.
12 months
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.
60 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days
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.
90 days
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.
180 days
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.
360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Collaborators

Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

  • Principal Investigator: Carlos CK Kalil, M.D., Ph.D., Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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