Arrhythmias, Cardiac
Conditions
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.
Interventions
DEVICEBIOTRONIK 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.
Sponsors
Biotronik SE & Co. KG
Irmandade Santa Casa de Misericórdia de Porto Alegre
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Remote Monitoring Data Transmission to BIOTRONIK's HMSC Platform | 12 months | 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. |
| Cardiologic Hospitalization | 12 months | Number of patients with at least one hospitalization related to cardiologic outcomes during the follow-up period. |
| Device Related Complication | 60 days | 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. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORCarlos CK Kalil, M.D., Ph.D.
Santa Casa de Misericórdia de Porto Alegre - Brugada Institute
Participant flow
Recruitment details
Recruitment Status: Completed Enrollment Start Date: November 24, 2021 Enrollment End Date (original): December 12, 2023 Enrollment End Date (actual): December 31, 2024 Study Completion Date (original): July 31, 2024 Study Completion Date (actual): July 31, 2025 Why Study Stopped Early: Enrollment stopped after 50 patients due to decreasing recruitment rate and sufficient data for primary endpoint analysis. Timeline extended due to Covid-19 crisis.
Pre-assignment details
Number of Participants Started: 50 Number of Participants Excluded Before Assignment: 0 Reason for Exclusion: Not applicable - all enrolled patients were assigned and implanted.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 14.9 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 3 Participants |
| Race/Ethnicity, Customized Brown | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 41 Participants |
| Region of Enrollment Brazil | 50 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 50 |
| other Total, other adverse events | 15 / 50 |
| serious Total, serious adverse events | 8 / 50 |
Outcome results
None listed