Clinical trial NCT04869527: Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
Official title: Simplifying Access to Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Continuous Home Monitoring in Brazil
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arrhythmias, Cardiac
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2021-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring an ICD implant

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.

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.

Primary outcomes:
measure: Atrial Flutter or Supraventricular Tachycardia
timeFrame: 12 months
Secondary outcomes:
measure: Successful transmission HMSC platform
timeFrame: 12 months
measure: Cardiologic hospitalization
timeFrame: 12 months
measure: Device related complication
timeFrame: 60 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre - Brugada Institute
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: BIOTRONIK Coml Médica LTDA
Study officials:
affiliation: Santa Casa de Misericórdia de Porto Alegre - Brugada Institute
name: Carlos CK Kalil, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: