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Atrial Fibrillation clinical trials

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NCT ID: NCT06322836 Enrolling by invitation - Clinical trials for Emergency Medical Services

A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home

Electra-1
Start date: February 7, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients. The main question[s] it aims to answer are: Primary objective: In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation). Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention. Secondary objectives: Safety endpoint: Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation). A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.

NCT ID: NCT06246825 Enrolling by invitation - Atrial Fibrillation Clinical Trials

the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea

PARABOLA
Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Rationale: Obstructive sleep apnea (OSA) is a highly prevalent, often undiagnosed, modifiable risk factor for atrial fibrillation (AF), as well as AF-related complications and treatment effectiveness. It is unclear which OSA-related pathophysiological mechanism, i.e. intrathoracic pressure shifts, hypoxemia or sympathovagal imbalance, plays the most dominant role, and a better understanding of these mechanisms could provide valuable information in future diagnostic and therapeutic strategies in this population. Objective: The primary objective is to assess the role of OSA-related pathophysiological mechanisms in the initiation of AF by a multi-parametric strategy that combines the estimated parameters. The main hypothesis is that intrathoracic pressure fluctuations are the predominant mechanism. The secondary objective is to validate a nonobtrusive sensing technology based on photoplethysmography (PPG) and diaphragm electromyography (dEMG) measurements as surrogates for gold standard technology based on invasive intraoesophageal pressure (PES) measurement. Study population: Adult patients with paroxysmal AF with nocturnal onset and high risk of OSA based on the STOP-BANG questionnaire. Study design: An observational study in a selected cohort. Subjects are recruited from the AF outpatient clinic of the Catharina Hospital, and referred to Kempenhaeghe Centre for Sleep Medicine for a one-night full PSG, with the addition of dEMG and PPG. The acquired data will be analysed at the Eindhoven Technical University. Main study parameters/endpoints: Primary endpoint: Identification of prognostic factors for the initiation of AF in relation to OSA-related pathophysiological mechanisms..nl

NCT ID: NCT06213285 Enrolling by invitation - Atrial Fibrillation Clinical Trials

APPEND-CT Registry

APPEND-CT
Start date: February 2024
Phase:
Study type: Observational

The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.

NCT ID: NCT06211413 Enrolling by invitation - Hypertension Clinical Trials

Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors

SENTINEL
Start date: February 7, 2024
Phase:
Study type: Observational

Acalabrutinib and Zanabrutinib are highly effective drugs used to treat Chronic Lymphocytic Leukemia, but they are associated with high blood pressure and abnormal heart rhythms. SENTINEL is an observational study that will use wearable technology to monitor heart rhythm and blood pressures at home to better understand how frequently patients are experiencing high blood pressure and/or abnormal heart rhythms.

NCT ID: NCT06168942 Enrolling by invitation - Stroke Clinical Trials

Laminar LAAX Pivotal IDE Study

Start date: February 22, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. This procedure is for patients with non-valvular atrial fibrillation who are at increased risk for stroke, but have a reason to seek an alternative to blood thinning medications. This clinical trial will compare the safety and efficacy of the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. Participants in this trial will be randomly assigned one-to-one (like flipping a coin) for treatment with either the Laminar Left Atrial Appendage Closure System or a commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

NCT ID: NCT06134752 Enrolling by invitation - Clinical trials for Persistent Atrial Fibrillation

Electroporation for Treatment of Atrial Fibrillation

ELECTROAF
Start date: December 5, 2023
Phase: N/A
Study type: Interventional

Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.

NCT ID: NCT06056557 Enrolling by invitation - Clinical trials for Atrial Fibrillation and Flutter

Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy

VIRTUE
Start date: September 28, 2023
Phase: N/A
Study type: Interventional

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.

NCT ID: NCT05992623 Enrolling by invitation - Atrial Fibrillation Clinical Trials

Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Start date: July 21, 2023
Phase: N/A
Study type: Interventional

The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks

NCT ID: NCT05923359 Enrolling by invitation - Atrial Fibrillation Clinical Trials

Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)

Start date: April 2024
Phase: N/A
Study type: Interventional

The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.

NCT ID: NCT05890274 Enrolling by invitation - Atrial Fibrillation Clinical Trials

Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO

Start date: September 4, 2022
Phase: N/A
Study type: Interventional

The goal of this study is to determine the effectiveness of a direct-to-provider virtual education program ("AF and EKG Interpretation Project ECHO") for primary care providers who manage patients with atrial fibrillation (AF). The main questions this study aims to answer are: 1. Will participants have improvement in knowledge and confidence in managing patients with atrial fibrillation after program completion? 2. Will quality and performance metrics improve at the patient level for program participants? Participants will be asked to: - Participate in 12 hours of virtual education sessions over twelve weeks via Zoom. - Complete a knowledge and confidence assessment online before the program starts and after its completion.