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COMPLETEDNA

Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile

NCT03940066•Fundación EPIC

Summary

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

Detailed Description

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is able to understand the nature of study and has provided written informed consent.
•Patient with Acute Coronary Syndrome, with or without elevation of the ST segment at the EKG (the last with elevation of troponins).
•Patient with coronariography at the episode of ACS showing severe lesions treated with stent.
•Patient with risk index for 6-month mortality (GRACE score) of more than 118.
•Patient with risk index for stroke (CHA2DS2-VACS score) of more than 2.

Exclusion Criteria

•Patient with history of AF.
•Patient with episodes of AF during admission at the current episode.
•Patient with pacemaker or ICD (implantable cardioverter-defibrillator) previously.
•Patient with indication of pacemaker or ICD in current or short-term phase.
•Patient is participating in another interventional clinical investigation.
•Patient is pregnant or breast feeding.
•Patient´s life-expectancy is less than 24 months.

Locations (1)

Hospital Universitario Marques de Valdecilla

Santander, Spain

Key Dates

Start Date

November 12, 2019

Primary Completion Date

April 8, 2024

Completion Date

June 1, 2024

Last Updated

April 6, 2025

Enrollment

169

ACTUAL participants

Conditions

Atrial FibrillationSyncopeTachycardiaArrhythmias, CardiacHeart Diseases

Interventions

Biomonitor-2 and Kardia mobile

DEVICE

No Intervention

OTHER

The CONFORM Pivotal Trial

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RECRUITINGNA

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

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Atrial Fibrillation (AF)

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RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

Medtronic Terminate AF Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia