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Atrial Fibrillation clinical trials

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NCT ID: NCT04320134 Not yet recruiting - Atrial Fibrillation Clinical Trials

cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation

NICE-AF
Start date: April 15, 2020
Phase:
Study type: Observational [Patient Registry]

Atrial fibrillation (AF) remains the most common sustained cardiac arrhythmia with prevalence and incidence continuously increasing worldwide. Current guidelines propose an etiological, symptom-based classification of the arrhythmia and mainly focused on its duration with consequent rhythm or rate-control strategies. Moreover, risk scores for atherothrombotic systemic or hemorrhagic events related to atrial fibrillation are principally based on patients cardiovascular history and risk factors. This approach do not consider relevant pathophysiological aspects that may play a pivotal role in triggering or perpetuating the arrhythmia, especially at its first occurrence. At this point, a crucial step would be deeply investigating AF clinical and pathophysiological features to guide a tailored diagnostical and therapeutic approach. Indeed, early recognition and proper characterization of triggers, substrates, autonomic system imbalance and modulating factors (drugs, electrolytes, etc) are of the utmost importance for AF care and management. Therefore, this large scale prospective observational study aims to evaluate clinical and pathophysiological features of patients with symptomatic and asymptomatic atrial fibrillation in different scenarios to understand possible distinctive characteristics warranting a personalized approach to the arrhythmia.

NCT ID: NCT04282850 Not yet recruiting - Atrial Fibrillation Clinical Trials

Ablation Versus Medical Management of Atrial Fibrillation in HFpEF

AMPERE
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

This is a prospective non-blinded randomized control pilot study comparing the effect of pulmonary vein isolation against medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction (HFpEF).

NCT ID: NCT04155879 Not yet recruiting - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Start date: November 2019
Phase: N/A
Study type: Interventional

Atrial fibrillation and inflammation are strongly correlated. The aim of this study is to evaluate whether inflammation markers (alpha Defensin) predict maintenance of sinus rhythm following cardioversion. A secondary aim is to evaluate the role of Colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.

NCT ID: NCT04141553 Not yet recruiting - Atrial Fibrillation Clinical Trials

Bolus vs IVP (Intravenous Push) Diltiazem for Atrial Fibrillation or Flutter

Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

The administration of intravenous non-dihydropyridine calcium channel blockers such as diltiazem for patients presenting in atrial fibrillation with rapid ventricular response, without evidence of pre-excitation, are recommended first-line therapies by the American Heart Association.1 Hypotension warrants careful consideration in the treatment of atrial fibrillation with a rapid ventricular response. Hemodynamic stability is a continuum, however, and rate control is often vital, particularly in patients who are refractory to electrical cardioversion [or who have underlying conditions such that tachycardia is not well tolerated]. Diltiazem has been utilized in dosing such as 2.5 mg/min in those with decreased blood pressure and atrial fibrillation with elevated ventricular rate.2 Lim et al. in 2002 demonstrated the effectiveness of a slow infusion of diltiazem 2.5 mg/min to a maximum of 50 mg to control rate in supraventricular tachycardia. The study of the slow infusion of diltiazem has been limited to supraventricular tachycardia. No literature exists evaluating the efficacy of such a gradual infusion in atrial fibrillation or atrial flutter, rhythms affecting 2.7 million to 6.1 million Americans.1,3 It can be reasoned that a gradual infusion of diltiazem will minimize side effects, predominantly hypotension, and perhaps even demonstrate efficacy in alleviating hypotension due to decreased stroke volume from excessive tachycardia. The proposed benefits of an infusion, as compared to a bolus, would allow for the termination of an infusion as soon as rate control is achieved thus limiting the potential for hypotension. With current evidence-based literature validating the superiority of non-dihydropyridine calcium channel blockers and questions surrounding present recommendations of weight based intravenous dosing, the authors suggest an inquiry into the utility of a gradual infusion of diltiazem for initial rate control in patients presenting with atrial fibrillation or flutter with or without hypotension related to excessive tachycardia. This is a prospective, randomized, double blind investigation to compare the effectiveness of standard IV (intravenous) push diltiazem at 0.25 mg/kg (to a maximum of 25 mg) over 2 minutes, with a potential repeat dose of 0.35 mg/kg if the initial dose is not effective versus a slow infusion of 50 mg of IV diltiazem diluted in 50 mL of 0.9% normal saline (NS) administered over 20 minutes. The investigators anticipate the data to be collected over the course of 2-3 years. These methods of diltiazem administration are already accepted practices at our institution and are consistent with current approved product labeling and professional judgment based upon clinical experience, and therefore the investigators do not foresee any additional risk to patients enrolled in our proposed study. In either treatment group, should hypotension or other clinical evidence of poor systemic perfusion, no additional IV diltiazem, or additional administration of a diltiazem infusion will be administered. The primary outcome measured will be the efficacy of treatment as defined by the obtainment of a heart rate of <110 beats/minute within 30 minutes of drug administration. Secondary outcomes evaluated will include the need for additional medications to achieve rate control including the need for repeat diltiazem bolus at 0.35 mg/kg, electrical cardioversion, admission, allergic reactions, and side effects including, but not limited to, systolic blood pressure less than 90 mmHg or bradycardia with heart rate less than 60 bpm.

NCT ID: NCT04134793 Not yet recruiting - Atrial Fibrillation Clinical Trials

Correlation of Atrial Fibrillation Recurrence After Bipolar Radiofrequency Ablation With microRNA Expression

Start date: October 2019
Phase:
Study type: Observational

The recurrence rate of atrial fibrillation (AF) after bipolar radiofrequency ablation was about 30%. Besides the factors, left atrium diameter, the duration of AF, NT-proBNP, and ejection fraction(EF), some studies demonstrated that the specific microRNA expression (miRNA1, miRNA19,miRNA23, miRNA409 ) showed the significant change in AF patients compared with normal sinus patients, who underwent catheter ablation. Therefore, the correlation of atrial fibrillation recurrence and above-mentioned microRNA after bipolar radiofrequency ablation remained unclear, although bipolar radiofrequency ablation had high rate of sinus.

NCT ID: NCT04109053 Not yet recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Start date: October 1, 2019
Phase:
Study type: Observational

Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

NCT ID: NCT04092621 Not yet recruiting - Sepsis Clinical Trials

Rapid Atrial Fibrillation Treatment Strategy

RAFTS
Start date: September 16, 2019
Phase: Phase 4
Study type: Interventional

Prospective, randomized, open-label clinical trial studying the treatment of new onset atrial fibrillation in critically ill patients with septic shock. Patients will be assigned to rhythm vs rate control strategies with various outcome measures assessed.

NCT ID: NCT04090437 Not yet recruiting - Atrial Fibrillation Clinical Trials

HCM-AF Ablation With ACUTUS

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

BACKGROUND About 1/4 of patients with hypertrophic cardiomyopathy (HCM) seem to develop atrial fibrillation (AF) over their life-span. Typically, symptoms of heart failure and especially shortness of breath get much worse once AF is present. Catheter ablation of AF in HCM has been proposed by several centres, but outcomes are much worse than in non-HCM AF. Accurate mapping of the arrhythmia is crucial with regard to improving the procedural outcome. Interestingly, intracardiac mapping during AF has demonstrated very long average cycle length during ongoing AF in HCM which should make identification of the critical re-entry/rotors much easier using dipole cardiac mapping (Acutus mapping system, Acutus Medical, CA, USA). POPULATION and PURPOSE This is a pilot trial recruiting a total of 20 patients with HCM and AF (paroxysmal or persistent with <12 months duration time in persistent AF) eligible for catheter ablation, without other significant structural heart disease Primary endpoints Safety: - Absence of acute adverse events due to the use of ACUTUS mapping system during AF ablation - Evidence of chronic adverse events due to the use of ACUTUS mapping system guided catheter ablation during the 12 months F/U period - Safety endpoint of the entire mapping and ablation strategy Efficacy: - Assessment on efficacy of ACUTUS mapping system guided AF ablation in HCM patients using a double-arm study design - RF time to termination of AF to SR Secondary endpoints - RF time to termination of AF to atrial tachycardia (AT) - Freedom from AF/flutter/tachycardia (> 30 sec) at the end of the 12 months follow up (F/U) period - Time to first recurrence of AF/flutter/tachycardia (> 30 sec) - Freedom of AF/flutter/tachycardia on previously failed anti-arrhythmic medication Ablation procedure First 10 patients (group 1): ablation will be carried out after acquisition of a left atrium (LA) and right atrium (RA) dipole map at baseline, pre and post administration of Adenosine IV. Then pulmonary vein isolation (PVI) as a first step and subsequent remap and ablation of all patterns of interest in the LA until restoration of sinus rhythm (SR) or decision to proceed with direct current cardioversion (DCCV, 360J). Second 10 patients (group 2): after the acquisition of a dipole map of LA and RA at baseline (pre and post Adenosine IV administration), ablation of all identified areas of interest (API) will be performed, followed by remap and finally PVI +/- DCCV. For all patients: final step will be the deployment of a RA isthmus line and demonstration of bidirectional block. FOLLOW UP Patients will be followed up at 3, 6, and 12 months.

NCT ID: NCT04062071 Not yet recruiting - Atrial Fibrillation Clinical Trials

Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal Atrial Fibrillation Patients

Start date: August 23, 2019
Phase:
Study type: Observational [Patient Registry]

Atrial fibrillation is a clinically significant cardiac arrhythmia that increases the risk of stroke by 3 to 4 times. Oral anticoagulation has been shown to mitigate stroke risk by two-thirds among patients with AF and is widely recommended in optimizing AF management.Direct oral anticoagulants have also been demonstrated to be superior to warfarin with respect to the risk of fatal bleeding and stroke prevention. However, the previous study finding highlighted a great gap between current guidelines and the clinical management of AF .Nonetheless, the decision for anticoagulant use is not straightforward.It is worth to investigate the updated prevalence of anticoagulant use, the reasons for not receiving anticoagulant, and the factors independently associated with anticoagulant refusal in patients with non-valvular atrial fibrillation.

NCT ID: NCT04058808 Not yet recruiting - Atrial Fibrillation Clinical Trials

MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss

MOTIVATE AF
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study is designed to look at the impact that support and motivation has on patients with Atrial Fibrillation's ability to lose weight and maintain this. We believe that weight loss has a positive impact on the reduction of symptoms of atrial fibrillation and can decrease the likelihood of the arrhythmia returning following cardio version. This study is designed for patients who have a diagnosis of Atrial Fibrillation and have a Body Mass Index greater than 27. In the study, we plan to provide support and motivation to patients with atrial fibrillation to encourage weight loss. There are several weight loss strategies available to follow. Information will be provided about each strategy to encourage informed choices. If the initial strategy chosen is not working, this can be change to a more suitable one as required. Follow up will be by telephone at 2 and 4 weeks then every month thereafter where you will be asked your weight and to clarify the weight loss strategy you are following. You will be seen at 6 and 12 months where you will have an ECG, BP check and your weight measured. A final telephone assessment will take place at 24 months. We hope that the research will in the future help patients with Atrial Fibrillation manage and maintain their weight loss to improve their symptoms and prevent recurrence of the arrhythmia. The results of this study could potentially change practice in our centre by providing more structured weight loss clinics for patients with Atrial Fibrillation