Excessive Supraventricular Activity and Atrial Fibrillation
ESA-AF
Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
ESA-AF
Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
Sponsor study identifier
observational
250
1 country
1
Study Start
November 1, 2022
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2020
Actual (reported)October 20, 2020
Actual (reported)November 1, 2022
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
Proportion of patients with at least one episode of atrial fibrillation with a duration of at least 30 seconds among patients with ESVEA on Holter recording as compared to patients without ESVEA.
10-14 days
the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.
2 years
Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.
2 years
ESVEA (Excessive supraventricular ectopic activity): Participants with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats.
Participants not meeting inclusion criteria
Holter recording with Zenicor Flex ECG during 14 days.
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
Individuals who have underwent Holter recording at Danderyd hospital after 2022.
Danderyd Hospital
Stockholm, Sweden
20 ml of plasma will be sampled at index and at 21 months in ESVEA and control group.
First Submitted
October 13, 2020
First Posted
October 20, 2020
Study Start
November 1, 2022
Actual (reported)Primary Completion
December 31, 2026
EstimatedValidation of a Novel Smartphone-based Method for Heart Rhythm Monitoring in the Home Environment
Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.
2 years
association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.
2 years
Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality.
4 years or longer
Blood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months. Troponin T, NTproBNP, Na, K, Creatinine. Sample for Biobank for future analysis.
To assess artery stiffness.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 6, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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