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

Arrhythmias, Cardiac Clinical Trial

— SAFE-DX-Home  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869527
• Other study ID #: TA118
• Status: Recruiting
• Start date: October 5, 2021
• Est. completion date: April 2, 2025

Study information

• Verified date: October 2023
• Source: Biotronik SE & Co. KG
• Contact: Luciano LC Carneiro, M.D., Ph.D.
• Phone: + 55 11 99424-1915
• Email: luciano.carneiro[@]biotronik.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: April 2, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Device:
• BIOTRONIK ICDs with DX Technology
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.

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericórdia de Porto Alegre - Brugada Institute	Porto Alegre	Rio Grande Do Sul
Brazil	BIOTRONIK Coml Médica LTDA	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG	Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Flutter or Supraventricular Tachycardia	First confirmed episode of AF or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to the HMSC.	12 months
Secondary	Successful transmission HMSC platform	Number of participants with successful transmissions received and stored on the HMSC platform	12 months
Secondary	Cardiologic hospitalization	Number of participants with hospital admissions related to cardiologic outcomes, at any time throughout the FU period;	12 months
Secondary	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.	60 days