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

Sponsor
Biotronik SE & Co. KG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04869527
Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre (Other)
54
Enrollment
2
Locations
29.9
Anticipated Duration (Months)
27
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: BIOTRONIK ICDs with DX Technology

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
54 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Simplifying Access to Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Continuous Home Monitoring in Brazil
Actual Study Start Date :
Oct 5, 2021
Anticipated Primary Completion Date :
Oct 5, 2023
Anticipated Study Completion Date :
Apr 2, 2024

Outcome Measures

Primary Outcome Measures

  1. Atrial Flutter or Supraventricular Tachycardia [12 months]

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

Secondary Outcome Measures

  1. Successful transmission HMSC platform [12 months]

    Number of participants with successful transmissions received and stored on the HMSC platform

  2. Cardiologic hospitalization [12 months]

    Number of participants with hospital admissions related to cardiologic outcomes, at any time throughout the FU period;

  3. Device related complication [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Casa de Misericórdia de Porto Alegre - Brugada Institute Porto Alegre Rio Grande Do Sul Brazil 90020-090
2 BIOTRONIK Coml Médica LTDA São Paulo Brazil 01533-000

Sponsors and Collaborators

  • Biotronik SE & Co. KG
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT04869527
Other Study ID Numbers:
  • TA118
First Posted:
May 3, 2021
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Arrhythmias, Cardiac

Study Results

No Results Posted as of Jun 16, 2022