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553 active trials for Atrial Fibrillation

POLARx Cardiac Cryoablation System Study

This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

Start: August 2020

Rate Control in Atrial Fibrillation II

The RATAF II study is a randomized, prospective, parallel group study, designed to compare the effects of two different drug regimens for rate control in permanent AF (atrial fibrillation). We will investigate on the difference in effects on exercise capacity, biomarkers (NT-proBNP (N-terminal pro-brain natriuretic peptide), troponins, hs-CRP), heart rate, echocardiographic measurements and symptoms. Our main hypothesis is that six months' treatment with the calcium channel blocker diltiazem will lower NT-proBNP and increase exercise capacity (peak VO2) compared to treatment with the beta blocker metoprolol in permanent AF.

Start: February 2016

Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

Start: May 2019

Analysis of Health Status of ?omorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection

Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection

Start: January 2021

Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart function and has been shown to be more effective than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ? 40%).

Start: January 2018

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.

Start: December 2019

Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation

This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.

Start: June 2021

Personalized Atrial Fibrillation Ablation With QDOT

Circumferential pulmonary vein isolation (PVI) has become a mainstay in the treatment of atrial fibrillation (AF), particularly in symptomatic patients with paroxysmal AF (PAF) intolerant or refractory to medical treatment. The safety and short-term performance of the novel QDOT® catheter (Biosense Webster, Irvine, CA, USA), that allows for a high-power short-duration (HPSD) ablation, has already been evaluated in the QDOT-FAST clinical study, with favorable data on feasibility and safety, and lowered fluoroscopy and procedure times needed to achieve complete PVI. HPSD ablation was based on immediate heat formation during the resistive phase, affecting a small tissue depth at 90 W/4 s (irrigation at 8 ml/min) with a temperature limit of 65ºC. However, up to date there are no randomized studies evaluating the real usefulness of the QDOT® catheter. Longer-term follow-up is still required to verify the long-term effectiveness and correlations between short-term follow-up and arrhythmia recurrence when using this catheter. The impact of this novel catheter, when used in conjunction with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT) to modulate the AI target at each ablation point, compared with a standard ablation protocol following the published CLOSE study criteria is already unknown.

Start: September 2021

Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System

The purpose of the BIO-AffectDX Study is to prospectively evaluate improvement from baseline in heart failure subjects with atrial fibrillation (AF) implanted with a two-lead CRT-DX system, with emphasis on a comparison of patient outcomes between AF subtypes.

Start: May 2021

A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes

In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. People with diabetes are more likely to have non-valvular atrial fibrillation (NVAF) compared to people who do not have diabetes. Having both NVAF and diabetes can increase the chances of developing other serious health conditions, like blood clots and strokes. People with NVAF may receive treatments to help lower the risk of blood clots. This can then help to lower the risk of having a stroke. Two of these treatments are rivaroxaban and warfarin. In this study, the researchers will look at how well rivaroxaban works and how safe it is compared to warfarin in routine clinical practice. The study will include men and women who are at least age 18 and who have NVAF and type 2 diabetes. The researchers in this study will use the participants' health information from an electronic database.

Start: August 2020

El DORADO STUDY (Evaluation of Delivery of Oxygen on Renal, Arrhythmia and Delirium Outcomes Study)

The study aims to develop a novel perioperative noninvasive delivery of oxygen (DO2) and hemodynamic index in the prediction of postoperative outcomes including post-operative acute kidney injury (POAKI), perioperative neurological cognitive disorders (PONCD) and post-operative atrial fibrillation (POAF). Our study also aims to study the effect of DO2 and hemodynamic parameters (measured noninvasively) on the development of PONCD, POAF and POAKI in cardiac surgical patients. We aim to develop a novel DO2 index and hemodynamic index predictive of PONCD, POAF and POAKI. The secondary aim would be to develop real-time machine learning aided algorithms in the analysis of noninvasive continuous hemodynamic and DO2 data, to predict and guide perioperative treatment of POCND, POAF and POAKI in the perioperative setting.

Start: September 2021

Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.

Start: March 2021

A Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation

This study is a prospective, randomized controlled study to compare overall clinical outcomes between High Power Short Duration (HPSD) and standard radiofrequency (RF) ablation settings for Atrial Fibrillation (AF) ablation in the treatment of subjects with paroxysmal or persistent Atrial Fibrillation.

Start: December 2019

Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients

The purpose of this pilot study is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously once weekly on top of standard care compared to standard care alone.

Start: October 2021

Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF

This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.

Start: November 2020

Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with NVAF who were not preselected.

Start: August 2015

Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up

Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate immediate and long term procedural success of Lifetech LAmbre™ occluders in patients.

Start: November 2018

Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry

Single-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate immediate and long term procedural success of Lifetech LAmbre™ occluders in patients.

Start: March 2020

Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview

Direct oral anticoagulants (Rivaroxaban, Apixaban and Dabigatran) are an alternative to anti-vitamin K drugs and low molecular weight heparins in many cardiovascular diseases. This new class of anticoagulants represents a particular and very promising advance: they are administered orally, their mechanism of action is rapid and direct on coagulation and their predictable pharmacological action allows for administration at fixed doses. In contrast to anti-vitamin K, there is no need for routine biological monitoring. However, their therapeutic range is narrow and there is no routine biological monitoring. Rigorous compliance is therefore necessary. In addition, there are no official validated recommendations either for the measurement of anticoagulant activity in certain emergency situations, or for the management of severe bleeding (except recently for Pradaxa®). Their correct use requires the training and involvement of health professionals as well as information and support for patients. Pharmaceutical interviews are one of the main ways in which pharmacists can ensure this security through personalized and optimal patient care. The purpose of these interviews is to: Reinforce the pharmacist's advisory, educational and preventive roles with patients; To enhance the pharmacist's expertise in the area of medication; To evaluate the patient's knowledge of his or her treatment; To assess the patient's knowledge of his or her treatment; To seek the patient's therapeutic adherence and help him or her to take ownership of his or her treatment; To evaluate, in the long term, the patient's appropriation of his or her treatment. In this way, they enable involvement with patients while providing a link between healthcare professionals, which is essential for optimal patient care. In recent years, numerous studies have been conducted on pharmaceutical interviews in the United Kingdom and the Netherlands. On the other hand, few studies have been conducted in France to evaluate the clinical impact of pharmaceutical interviewing in medical services. The aim of this study is to compare patients' knowledge of direct oral anticoagulants between 2 cardiology departments offering or not a pharmaceutical interview.

Start: January 2021

Characterization and Prediction of Atrial Fibrillation-caused Adverse Events After Hospital Discharge for Cardiac Surgery

The purpose of the research is to identify the frequency and severity of adverse events related to atrial fibrillation that occur after discharge from hospital where the patient underwent cardiac surgery. The Specific Aims of the proposed study are to: Identify the predictors of postoperative atrial fibrillation after discharge from hospital. Identify the frequency of readmission to hospital, or other resource use such as Emergency Department or outpatient visit, for the treatment or prophylaxis of postoperative AF and consequent stroke or bleeding outcomes. Identify the risks for stroke, death and other morbidity in patients after cardiac surgery and the effect of postoperative AF upon subsequent stroke or bleeding outcomes.

Start: January 2018