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

NCT04869527 | Active Not Recruiting

• 1 other identifier: TA118
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Successful transmission HMSC platform

  12 months

• Cardiologic hospitalization

  12 months

• Device related complication

  60 days

Interventions

BIOTRONIK ICDs with DX Technology DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring an ICD implant

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (2)

Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

BIOTRONIK Coml Médica LTDA

São Paulo, 01533-000, Brazil

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos CK Kalil, M.D., Ph.D.

  Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: October 5, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)