Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04869527
Other study ID # TA118
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 5, 2021
Est. completion date April 2, 2025

Study information

Verified date October 2023
Source Biotronik SE & Co. KG
Contact Luciano LC Carneiro, M.D., Ph.D.
Phone + 55 11 99424-1915
Email luciano.carneiro@biotronik.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date April 2, 2025
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Brazil Santa Casa de Misericórdia de Porto Alegre - Brugada Institute Porto Alegre Rio Grande Do Sul
Brazil BIOTRONIK Coml Médica LTDA São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Biotronik SE & Co. KG Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Successful transmission HMSC platform Number of participants with successful transmissions received and stored on the HMSC platform 12 months
Secondary Cardiologic hospitalization Number of participants with hospital admissions related to cardiologic outcomes, at any time throughout the FU period; 12 months
Secondary Device related complication 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. 60 days
See also
  Status Clinical Trial Phase
Completed NCT03079726 - Use of Device Data to Predict Frailty in Individuals
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT05404789 - Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia N/A
Recruiting NCT04554160 - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Recruiting NCT04471584 - Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors N/A
Recruiting NCT02906189 - Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices N/A
Completed NCT02466633 - Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias N/A
Completed NCT02550340 - Munich Study for Beer Related ECG Change Workup N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Withdrawn NCT04556240 - RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
Active, not recruiting NCT05481359 - AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
Recruiting NCT05047835 - Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
Not yet recruiting NCT05957315 - Mobile Cardiac Outpatient Telemetry for Unexplained Syncope N/A
Not yet recruiting NCT05974306 - Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System N/A
Completed NCT06260670 - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation N/A
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed NCT04943354 - Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure N/A
Recruiting NCT03857711 - Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation) N/A