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

Biotronik

Status: Active, not recruiting

Conditions: Arrhythmias, Cardiac

Treatments: Device: BIOTRONIK ICDs with DX Technology

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04869527

TA118

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.