AzTrials
AzTrials

Arrhythmias, CardiacSAFE-DX-HomeNCT04869527

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

An observational study of Arrhythmias, Cardiac, run by Biotronik SE & Co. KG at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arrhythmias, Cardiac
What is being tested?
BIOTRONIK ICDs with DX Technology
Type of treatment
Medical device
How many people
56 participants
Where
2 sitesBrazil
Study dates
24 Nov 2021to 31 Jul 2025
How long will I take part?
12 Months
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients requiring an ICD implant

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

    Porto Alegre, Rio Grande do Sul, 90020-090

  • BIOTRONIK Coml Médica LTDA

    São Paulo, 01533-000

Other trials in Brazil

About this study

Official title: 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).

Read the 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.
Being tested
BIOTRONIK ICDs with DX Technology
Medical subject headings
Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIOTRONIK ICDs with DX TechnologyDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 12 months

Secondary outcomes (3)

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

    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.

    Measured: 12 months

  2. Cardiologic Hospitalization

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

    Measured: 12 months

  3. Device Related Complication

    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.

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start24 Nov 2021
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
56 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869527
Sponsor's protocol ID
TA118
Acronym
SAFE-DX-Home
Status last verified
Oct 2024
First submitted
28 Apr 2021
Last updated
9 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.

    PubMed 22236222

  • Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA; MOST Investigators. Atrial high rate episodes detected by pacemaker diagnostics predict death and stroke: report of the Atrial Diagnostics Ancillary Study of the MOde Selection Trial (MOST). Circulation. 2003 Apr 1;107(12):1614-9. doi: 10.1161/01.CIR.0000057981.70380.45. Epub 2003 Mar 24.

    PubMed 12668495

  • Peterson PN, Varosy PD, Heidenreich PA, Wang Y, Dewland TA, Curtis JP, Go AS, Greenlee RT, Magid DJ, Normand SL, Masoudi FA. Association of single- vs dual-chamber ICDs with mortality, readmissions, and complications among patients receiving an ICD for primary prevention. JAMA. 2013 May 15;309(19):2025-34. doi: 10.1001/jama.2013.4982.

    PubMed 23677314

  • Matlock DD, Peterson PN, Wang Y, Curtis JP, Reynolds MR, Varosy PD, Masoudi FA. Variation in use of dual-chamber implantable cardioverter-defibrillators: results from the national cardiovascular data registry. Arch Intern Med. 2012 Apr 23;172(8):634-41; discussion 641. doi: 10.1001/archinternmed.2012.394.

    PubMed 22529229

  • Dewland TA, Pellegrini CN, Wang Y, Marcus GM, Keung E, Varosy PD. Dual-chamber implantable cardioverter-defibrillator selection is associated with increased complication rates and mortality among patients enrolled in the NCDR implantable cardioverter-defibrillator registry. J Am Coll Cardiol. 2011 Aug 30;58(10):1007-13. doi: 10.1016/j.jacc.2011.04.039.

    PubMed 21867834

  • Dries DL, Exner DV, Gersh BJ, Domanski MJ, Waclawiw MA, Stevenson LW. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Sep;32(3):695-703. doi: 10.1016/s0735-1097(98)00297-6.

    PubMed 9741514

  • Lee DS, Krahn AD, Healey JS, Birnie D, Crystal E, Dorian P, Simpson CS, Khaykin Y, Cameron D, Janmohamed A, Yee R, Austin PC, Chen Z, Hardy J, Tu JV; Investigators of the Ontario ICD Database. Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010 Feb 23;55(8):774-82. doi: 10.1016/j.jacc.2009.11.029.

    PubMed 20170816

  • Healey JS, Toff WD, Lamas GA, Andersen HR, Thorpe KE, Ellenbogen KA, Lee KL, Skene AM, Schron EB, Skehan JD, Goldman L, Roberts RS, Camm AJ, Yusuf S, Connolly SJ. Cardiovascular outcomes with atrial-based pacing compared with ventricular pacing: meta-analysis of randomized trials, using individual patient data. Circulation. 2006 Jul 4;114(1):11-7. doi: 10.1161/CIRCULATIONAHA.105.610303. Epub 2006 Jun 26.

    PubMed 16801463

  • Castellanos A, Berkovits BV, Castillo CA, Befeler B. Sextapolar catheter electrode for temporary sequential atrioventricular pacing. Cardiovasc Res. 1974 Sep;8(5):712-4. doi: 10.1093/cvr/8.5.712. No abstract available.

    PubMed 4434373

  • Curry PV, Raper DA. Single lead for permanent physiological cardiac pacing. Lancet. 1978 Oct 7;2(8093):757-9. doi: 10.1016/s0140-6736(78)92647-8.

    PubMed 80685

  • Ovsyshcher IE, Crystal E. VDD pacing: under evaluated, undervalued, and underused. Pacing Clin Electrophysiol. 2004 Oct;27(10):1335-8. doi: 10.1111/j.1540-8159.2004.00635.x. No abstract available.

    PubMed 15511240

  • Shurrab M, Elitzur Y, Healey JS, Gula L, Kaoutskaia A, Israel C, Lau C, Crystal E. VDD vs DDD pacemakers: a meta-analysis. Can J Cardiol. 2014 Nov;30(11):1385-91. doi: 10.1016/j.cjca.2014.04.035. Epub 2014 May 28.

    PubMed 25228132

  • Gradaus R, Gonska BD, Stellbrink C, Cron T, Tebbenjohanns J, Blomstrom-Lundqvist C, Himmrich E, Salerno JA, Osswald S, Gommer ED, Van Veen BK, Bocker D. European clinical experience with a dual chamber single pass sensing and pacing defibrillation lead. Pacing Clin Electrophysiol. 2002 Jul;25(7):1079-86. doi: 10.1046/j.1460-9592.2002.01079.x.

    PubMed 12164450

  • Gradaus R, Block M, Dorszewski A, Schriever C, Hammel D, Scheld HH, Borggrefe M, Breithardt G, Bocker D. Implantation of a dual chamber pacing and sensing single pass defibrillation lead. Pacing Clin Electrophysiol. 2001 Apr;24(4 Pt 1):416-23. doi: 10.1046/j.1460-9592.2001.00416.x.

    PubMed 11341077

  • Niehaus M, de Sousa M, Klein G, Korte T, Pfeiffer D, Walles T, Raymondos K, Tebbenjohanns J. Chronic experiences with a single lead dual chamber implantable cardioverter defibrillator system. Pacing Clin Electrophysiol. 2003 Oct;26(10):1937-43. doi: 10.1046/j.1460-9592.2003.00299.x.

    PubMed 14516332

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmias, Cardiac, run by Biotronik SE & Co. KG at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04869527, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in