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

January 15, 2024 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

Recruiting

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 (Estimated)

54

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01533-000
        • Not yet recruiting
        • BIOTRONIK Coml Médica LTDA
        • Contact:
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Recruiting
        • Santa Casa de Misericórdia de Porto Alegre - Brugada Institute
        • Contact:
        • Principal Investigator:
          • Carlos Kalil, PhD

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
Atrial Flutter or Supraventricular Tachycardia
Time Frame: 12 months
First confirmed episode of AF or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to the HMSC.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful transmission HMSC platform
Time Frame: 12 months
Number of participants with successful transmissions received and stored on the HMSC platform
12 months
Cardiologic hospitalization
Time Frame: 12 months
Number of participants with hospital admissions related to cardiologic outcomes, at any time throughout the FU 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

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

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)

October 5, 2021

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

April 2, 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 (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

October 1, 2023

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

Yes

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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