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"De Novo" Atrial Fibrillation in Patients With Heart Failure: Incidence; Predictors and Relevance.

NCT04755010 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2021-02-15

No results posted yet for this study

Summary

Atrial fibrillation (AF) represents a problem of great implications to patients with heart failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the presence of HF. Both conditions share risk factors and the presence of the one worsens the progress of the other. Therefore, the AF is not only relevant in terms of thromboembolic events. Timing of AF progression seems to be associated with an increase in all causes of mortality. Although, it is estimated that between 30%-40% of the patients with HF develop AF, given that in many cases it occurs with no apparent symptoms for the patients, is considered that the number of affected patients is greater. Since silent AF poses a problem of great impact in patients with HF, monitoring through continuous electrocardiographic registry could be useful in those patients with a higher risk of thromboembolic events. The purpose of this study is to understand the mechanism and biological and clinical relevance of the AF from a holistic approach. Trying to distinguish the symptomatic AF from the silent one using the implementation of insertable cardiac devices. The purpose of this study is 1. To determine in which percentage of patients with HF, episodes of AF both symptomatic and asymptomatic occur, as well as if the presence of AF represents an irrelevant fact in the progression of the insufficiency or in the contrary, it is the cause of the HF patients clinical decline. 2. To examine the presence of triggers of AF in patients with HF and to identify the presence of clinical markers, image markers of the atrium and left ventricle, as well as biomarkers which allow the risk of stratification and could mean future therapeutic targets.

Conditions

Interventions

DEVICE

Linq II implantable cardiac monitor

Implantation of Linq II implantable cardiac monitor

Sponsors & Collaborators

  • University of Salamanca

    collaborator OTHER

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • Hospital Universitario San Juan de Alicante

    collaborator OTHER

  • Hospital Clinico Universitario de Santiago

    lead OTHER

Principal Investigators

  • moises rodriguez mañero, PhD · Clínico Universitario de Santiago de Compostela

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-10-01
Completion
2023-11-01
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04755010 on ClinicalTrials.gov