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- Ensaio Clínico NCT05103579
Design and Rationale of the Assessment of the MindMics Recording System
Design and Rationale of the Assessment of the Mindmics Recording System to Collect Data to Facilitate the Development of an Algorithm to Discriminate Atrial Fibrillation From Sinus Rhythm
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Introduction:
This study will evaluate the efficacy of the MindMics earbud recording apparatus to record data from patients with known atrial fibrillation as well as those in sinus rhythm. Patients in the clinic and patients with atrial fibrillation scheduled to undergo elective direct-current cardioversion will be the chosen subjects. This process will select a variety of patients to allow evaluation of the Mindmics apparatus's ability to collect data from patients with normal as well as abnormal cardiac rhythms.
Hypotheses
The MindMics earbud device is capable of recording normal cardiac rhythms in patients noninvasively using earbud device in a noninvasive manner. The same apparatus may be capable of discerning atrial fibrillation compared with normal sinus rhythm. This will be evaluated by collecting information from patients with atrial fibrillation in the office as well as those scheduled to undergo an elective direct-current cardioversion procedure. A timed recording of the clinical rhythm while wearing the apparatus will allow simultaneous recording of data from an ECG recording (documenting the patient's clinical arrhythmia) at the same time the MindMics earbud records its data obtained during the ECG recording of the patient's rhythm. For those patient scheduled for direct current cardioversion, the patient will undergo the direct-current cardioversion and a second recording will be obtained during sinus rhythm afterwards allowing an appropriate comparison of the differences in the recording sets.
The objective is to demonstrate differences between recordings made in atrial fibrillation and those in sinus rhythm that can be used to develop an algorithm allow discernment between atrial fibrillation and sinus rhythm.
OVERALL DESIGN
This study is designed to collect sequential patient's in a nonrandomized unblinded procedure designed to collect information using the apparatus to document its capability of recording cardiac rhythm data, then using this recorded data to determine whether the patient has an abnormal cardiac rhythm. Initial efforts will be directed to develop an algorithm to detect atrial fibrillation.
Patients will be recruited from inpatients at Palmetto Tuomey Medical center or in the outpatient office during routine office visits for patients with clinical arrhythmias for elective recording for group 1. Group 2 patients will be recruited prior to direct-current cardioversion. Both groups will be explained the study, what is their participation, potential risk and expectations for their participation in the study.
Once selected each patient will be required to sign a study protocol consent form before actual entry into the study. Once the consent is completed, the patients will be connected to the Mindmics apparatus as well as an electrocardiographic recording system. The study participant will lie quietly collecting simultaneous electrocardiographic data and data from the Mindmics earbuds. Group 1 patients will be identified as outpatients during their routine office visits will have 15 minutes of recording in a patient examination room during the office visit. Group 2 patients undergoing Direct-Current Cardioversion will have 15 minutes of recording prior to the cardioversion procedure and 15 minutes of recording after completion of the cardioversion procedure.
NUMBER OF PARTICIPANTS
Approximately 25 patients will be recruited for group 1 from inpatient or outpatient office visits. These patients will have persistent atrial fibrillation during the office visit. If necessary would consider increasing the total number of patients to 50 in this group Approximately 25 patients will be recruited for group 2 prior to direct-current cardioversion allowing collection of data from before and after cardioversion to document differences in recordings during sinus rhythm after having successful cardioversion from atrial fibrillation. While certainly some patients will revert back to atrial fibrillation and not have periods of sinus rhythm is anticipated the vast majority of patients will have successful cardioversions long enough to record at least the 15 minutes post cardioversion in sinus rhythm. If necessary would consider increasing the total number of patients to 50 in this group
DURATION The total duration of involvement for each study participant is for the duration of the recording interval. Group 1 participants will have a 15-minute recording interval while those in group to will have 2 sessions of 15 minutes each separated by the direct current cardioversion. No further participation will be required.
All data collected during the study will be kept by Mindmics. All data collected in the study will be de-identified
OUTCOME MEASURES and STATISTICAL ANALYSIS
Each recording will be evaluated by Mindmics to evaluate the ability of the recording apparatus to provide data that would lead to clear discernment of the patient's cardiac rhythm as well as rate related phenomena. At this juncture, it is anticipated the collected data will be used to develop and test algorithms yet to be developed and to make clinical determinations of the cardiac rhythms.
Initial data will be evaluated to determine if the Mindmics earbuds are capable of discriminating atrial fibrillation from normal sinus rhythm. For that reason, it is not possible to suggest a statistical method until it is determined the device data can be used to evaluate differences in cardiac rhythm.
SAFETY
There is no potential harm or injury associated with the research. The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. There are no potential risks with respect to psychological, sociological, economic, or legal. The overall risk of the device in minimum.
Potential Benefit to Participants This study is performed in such a manner that it is not anticipated there would be an ability to provide diagnostic data that may be helpful for the study participants.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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South Carolina
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Sumter, South Carolina, Estados Unidos, 29150
- Prisma Health
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Approximately 25 patients will be recruited for group 1 from inpatient or outpatient office visits.
Approximately 25 patients will be recruited for group 2 prior to direct-current cardioversion allowing collection of data from before and after cardioversion to document differences in recordings during sinus rhythm after having successful cardioversion from atrial fibrillation.
Descrição
Inclusion Criteria:
- AFib
Exclusion Criteria:
- N/A
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Transversal
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Patients with AFib
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Patients rhythms was recorded using MindMics device
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Normal patients
Normal patients without AFib
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Patients rhythms was recorded using MindMics device
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Performance of the MindMics device for detecting Atrial Fibrillation based on inter-beat intervals
Prazo: 30 minutes
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Sensitivity and specificity for detecting Atrial Fibrillation using inter-beat intervals and statistical measures based on inter-beat intervals
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30 minutes
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00096535
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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