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Atrial Fibrillation clinical trials

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NCT ID: NCT04612335 Recruiting - Atrial Fibrillation Clinical Trials

Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)

Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). The RACE7 ACWAS showed that a wait-and-see approach (WAS) in patients with recent-onset AF (rate control for symptom relief followed by delayed cardioversion if needed <48h) allows spontaneous conversion to sinus rhythm in 69% of patients, obviating active cardioversion. Recurrences within one month were seen in 30% of patients in both groups, i.e. the initially chosen strategy did not affect the recurrence pattern. Considering the latter, it remains unclear whether cardioversion is needed at all, especially since cardioversion strategy does not seem to affect behaviour of the arrhythmia over time. Instead of cardioversion a watchful-waiting rate control strategy may be appropriate as initial strategy. This allows observing the electrical and clinical behavior of arrhythmia, providing a solid basis for comprehensive and effective early rhythm control. This study is a multi-center clinical randomized controlled trial to show non-inferiority of watchful-waiting with rate control versus routine care in terms of prevalence of sinus rhythm at 4 weeks follow-up, using a novel telemonitoring infrastructure to guide rate control during follow-up.

NCT ID: NCT04609202 Recruiting - Atrial Fibrillation Clinical Trials

Person Centered Nurse Led Atrial Fibrillation Care

Start date: October 19, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.

NCT ID: NCT04609059 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

First-in-Patient Study for Sing le Dose of M201-A Hydrochloride Injection in Japanese Patients With Paroxysmal Atrial Fibrillation

Start date: May 7, 2019
Phase: Phase 2
Study type: Interventional

First-in-Patient Study for sing le dose of M201-A hydrochloride injection in Japanese patients with paroxysmal atrial fibrillation.

NCT ID: NCT04606693 Recruiting - Clinical trials for Atrial Fibrillation, Persistent

Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates

SLEEP-AF
Start date: November 5, 2020
Phase: N/A
Study type: Interventional

The present prospective cohort study (not randomized) analyses the value of screening and treatment of SAHS in the management of patients with AF refractory to antiarrhythmics drugs, potentially candidates for ablation. Patients at low risk of suffering from SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit. Patients with high or intermediate risk of SAHS, will undergo respiratory polygraphy. If the result is positive, they will be treated as standard for this syndrome and their heart rate will be monitored for 3 months. After this, the patient's arrhythmic load will be reevaluated differentiating patients into two groups, those that must be ablated from those that have improved their condition and the clinical criteria is no longer ablation but follow-up.

NCT ID: NCT04602169 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF

RECONNECT
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear. With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.

NCT ID: NCT04600245 Recruiting - Atrial Fibrillation Clinical Trials

Evaluation of CARTOSOUND FAM Software for Accurate Reconstruction of the Left Atrium

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The aim of the present study is to compare the LA reconstruction obtained with CartoSound-FAM software and The M-FAM software to the Carto Merge 3D reconstruction and FAM in consecutive patients referred for AF ablation.

NCT ID: NCT04594746 Recruiting - Atrial Fibrillation Clinical Trials

Oral Amiodarone for Acute Cardioversion of Atrial Fibrillation Study

AAA
Start date: February 3, 2022
Phase: Phase 4
Study type: Interventional

The investigators will seek to determine the safety and efficacy of high-dose amiodarone (2000mg), given as a single uniform oral dose, for the treatment of acute atrial fibrillation in both a hospital inpatient and ambulatory outpatient setting. The investigators will conduct a placebo-controlled randomized trial, with outcome ascertainment at 48h.

NCT ID: NCT04593498 Recruiting - Atrial Fibrillation Clinical Trials

Excessive Supraventricular Activity and Atrial Fibrillation

ESA-AF
Start date: November 1, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT04586972 Recruiting - Clinical trials for Nonvalvular Atrial Fibrillation

Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;

SOFIA
Start date: September 23, 2020
Phase:
Study type: Observational [Patient Registry]

The main objective of this study is to realize an observational "real life" study conducted in French geriatric settings, to assess safety and efficacy in ≥ 80 year-old patients with nonvalvular Atrial fibrillation (AF) newly treated with Apixaban. Moreover, in this geriatric population the adequacy of Apixaban dosage and events (bleeding and stroke) will be assessed.

NCT ID: NCT04577859 Recruiting - Complication Clinical Trials

Oesophageal Protection Study: A Multicentre Study.

IMPACT II
Start date: March 10, 2022
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the oesophagus caused by thermal energy being transmitted to the oesophagus from the heart. The oesophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe oesophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In a recent study, it was shown that a more advanced type of oesophageal probe that cools the oesophagus during ablation is better at protecting the oesophagus from ablation-related injury compared to the standard care probe currently used. As it was a single-centre study, more evidence is required before knowing if this type of probe is more effective in protecting the oesophagus. The purpose is to run a multi-centre randomized study to compare the safety of AF ablation when there is protection by the oesophageal cooling probe versus the standard of care oesophageal temperature monitoring probe. This means that there is a 50:50 chance of the new cooling probe being used during AF ablation for participants.