Trial Outcomes & Findings for Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil. (NCT NCT04869527)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

56 participants

Primary outcome timeframe

12 months

Results posted on

2026-07-09

Participant Flow

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.

Number of Participants Started: 50 Number of Participants Excluded Before Assignment: 0 Reason for Exclusion: Not applicable - all enrolled patients were assigned and implanted.

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	Single Arm: SAFE-DX-HOME Group Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Overall Study STARTED	50 50
Overall Study COMPLETED	46 46
Overall Study NOT COMPLETED	4 4

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm: SAFE-DX-HOME Group Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Overall Study Death	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Age, Continuous	59.9 years STANDARD_DEVIATION 14.9 • n=20 Participants
Sex: Female, Male Female	15 Participants n=20 Participants
Sex: Female, Male Male	35 Participants n=20 Participants
Race/Ethnicity, Customized Caucasian	41 Participants n=20 Participants
Race/Ethnicity, Customized Brown	4 Participants n=20 Participants
Race/Ethnicity, Customized Black	3 Participants n=20 Participants
Race/Ethnicity, Customized Asian	2 Participants n=20 Participants
Region of Enrollment Brazil	50 Participants n=20 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All 50 enrolled patients were included in the analysis population. No patients were excluded after enrollment.

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.

Outcome measures

Outcome measures
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes	16 participants

SECONDARY outcome

Timeframe: 12 months

Population: All 50 enrolled patients were included in the analysis of Home Monitoring transmission performance.

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.

Outcome measures

Outcome measures
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Successful Remote Monitoring Data Transmission to BIOTRONIK's HMSC Platform	92.4 percentage of days Standard Deviation 14.1

SECONDARY outcome

Timeframe: 12 months

Population: All 50 enrolled patients were included in the analysis of cardiologic hospitalizations.

Number of patients with at least one hospitalization related to cardiologic outcomes during the follow-up period.

Outcome measures

Outcome measures
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Cardiologic Hospitalization	1 Participants

SECONDARY outcome

Timeframe: 60 days

Population: All 50 enrolled patients were included in the analysis of device-related complications.

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.

Outcome measures

Outcome measures
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Device Related Complication	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed.

Outcome measures

Outcome measures
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Cumulative Incidence of First AF/AFL/SVT Episode at 90 Days	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days

Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 180 days. No hypothesis testing was performed.

Outcome measures

Outcome measures
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Cumulative Incidence of First AF/AFL/SVT Episode at 180 Days	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 360 days

Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 360 days. No hypothesis testing was performed.

Outcome measures

Outcome measures
Measure	Single Arm: SAFE-DX-HOME Group n=50 Participants Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Cumulative Incidence of First AF/AFL/SVT Episode at 360 Days	17 Participants

Adverse Events

Single Arm: SAFE-DX-HOME Group

Serious events: 8 serious events

Other events: 15 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm: SAFE-DX-HOME Group n=50 participants at risk Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Surgical and medical procedures Ventricular lead perforation	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Surgical and medical procedures Ventricular lead dislodgement	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Gastrointestinal disorders Acute gastrointestinal bleeding	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Cardiac disorders Multi-organ failure (chagasic heart failure, hypothyroidism)	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Infections and infestations Septic arthritis	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Cardiac disorders Chest pain (coronary artery disease)	4.0% 2/50 • Number of events 2 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Metabolism and nutrition disorders Mental confusion/metabolic encephalopathy	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Cardiac disorders Ventricular fibrillation (shock delivered)	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Infections and infestations Fever of unknown origin	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Cardiac disorders Paroxysmal atrial fibrillation	4.0% 2/50 • Number of events 2 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Nervous system disorders Stroke-like symptoms	2.0% 1/50 • Number of events 1 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.

Other adverse events

Other adverse events
Measure	Single Arm: SAFE-DX-HOME Group n=50 participants at risk Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring.
Cardiac disorders Atrial tachycardia	10.0% 5/50 • Number of events 5 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Cardiac disorders Paroxysmal atrial fibrillation	8.0% 4/50 • Number of events 4 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Cardiac disorders Ventricular fibrillation	100.0% 2/2 • Number of events 2 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
Cardiac disorders Supraventricular Tachycardia (SVT)	8.0% 4/50 • Number of events 4 • 12 months Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.

Additional Information

Dr. LUCIANO JANNUZZI CARNEIRO, Project Manager

BIOTRONIK Co.Med. LTDA (BRAZIL)

Phone: +55 11 99424-1915

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place