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

NCT ID: NCT04869527

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2025-04-30

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).

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.

Conditions

Arrhythmias, Cardiac

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role: collaborator

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos CK Kalil, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

Locations

Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

Porto Alegre, Rio Grande do Sul, Brazil

BIOTRONIK Coml Médica LTDA

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

TA118

Identifier Type: -

Identifier Source: org_study_id