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Atrial Fibrillation clinical trials

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NCT ID: NCT06152406 Recruiting - Atrial Fibrillation Clinical Trials

Ablate and Pace HIS Study

Start date: November 24, 2023
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and estimates suggest its prevalence is increasing. Despite the advances in AF ablation strategies, the outcome of ablation procedures in persistent AF is still unsatisfactory. In addition, many patients are not candidates for ablation due to advanced age, comorbidities and previous failed ablation procedures. It is well known that there is no mortality benefit from rhythm versus rate control strategy in AF, therefore the increased number of AV node ablation and pacemaker insertion for patients with symptomatic AF with uncontrolled heart rate. Following AV node ablation, it is understandable that these patients will be paced 100% of the time where the value of physiological pacing will be at its most. The current standard practice is to pace the right ventricle for this cohort of patients unless they have severe LV systolic dysfunction when a biventricular pacing might be recommended. Previous data showed that RV pacing only can lead to deterioration of LV function, worsening of heart failure symptoms and increased mortality. HIS bundle pacing is a novel technique of pacing through placing the pacemaker lead on the junction box between the top and bottom chamber of the heart. This will allow the utilisation of the normal/intrinsic HIS Purkinjie (eclectic cables) to stimulate the ventricles. This can offer a physiological pacing modality and reduce pacing induced cardiomyopathy specially in pacing dependent pacing. The Ablate and Pace HIS Study proposes that the new method of HIS pacing is safe, effective and superior to the existing method of RV pacing in patients with atrial fibrillation who demonstrate signs of heart failure.

NCT ID: NCT06151652 Recruiting - Clinical trials for Postoperative Atrial Fibrillation

Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

ALA is administered orally since it is without difficulty absorbed in the stomach. ALA goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. This has encouraged us to use an efficient anti-oxidant and anti-inflammatory agent, alpha-lipoic acid (biochemical) as a relevant option to prevent POAF.

NCT ID: NCT06145906 Recruiting - Atrial Fibrillation Clinical Trials

Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation

Start date: December 26, 2023
Phase:
Study type: Observational

The success rate of single-procedure atrial arrhythmia-free survival particularly ranged from 40% to 66% in persistent AF ablation. However, The surgical Cox maze III procedure has been established to be an effective curative strategy for AF with an AF-free survival rate of more than 95%. The main reason is the difficulty of creating continuous, transmural, and durable lesions by catheter ablation, especially when the procedure is performed on some complex anatomical structures in which epicardial muscular bundles may serve as components of the reentrant circuits. The durability of the conduction block is a crucial factor for long-term effective AF ablation since previous studies reported that the reconnected Pulmonary veins contributed to the atrial tachycardia recurrence after persistent AF ablation. In addition, it is possible that the inadequate lesions accidentally produce new arrhythmogenic substrates. Therefore, new and better techniques are always chosen to minimize the reconnection of Pulmonary vein isolation (PVI) and additional ablation. For paroxysmal AF, the ablation strategy of PVI plus superior vena cava isolation is chosen while PVI, superior vena cava isolation, and linear ablation of linear ablations of the mitral isthmus, roofline and posterior wall line of the left atrium, and cavotricuspid isthmus (CTI) for persistent AF. Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds was regarded as an AF recurrence after a 3-month blanking period. The primary outcome was defined as 12-month atrial arrhythmia-free survival. The secondary outcomes include the block rate of PVI, superior vena cava isolation, and all linear ablations.

NCT ID: NCT06144632 Recruiting - Clinical trials for Drug Refractory Paroxysmal Atrial Fibrillation

A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF

SMARTPULSE PAF
Start date: December 7, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.

NCT ID: NCT06134739 Recruiting - Atrial Fibrillation Clinical Trials

Arterial Embolism After Catheter Ablation of Atrial Fibrillation. ATRIAL FIBRILLATION

EMBOL-AF
Start date: January 2, 2024
Phase:
Study type: Observational

The EMBOL-AF is a multicenter, international, observational study designed as a retrospective registry that will investigate the characteristics of systemic arterial embolic events after treatment of atrial fibrillation by catheter ablation. Due to the retrospective nature of the study, the registry is specially focused on cerebral embolism (stroke and TIA) because these are not only the most frequent and clinically relevant but also the most susceptible to underreporting. However, all embolism associated to AFAbl will be included. This study will gather all clinically relevant aspects and data of all cases of arterial embolism that have occurred over the last 5 years in the centers that will participate in the registry. Based on these reported cases, the incidence, management and outcomes of embolic events (particularly stroke and TIA) will be studied.

NCT ID: NCT06128174 Recruiting - Clinical trials for Long-standing Persistent AF

LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation

LS-PersAFone
Start date: January 23, 2024
Phase: N/A
Study type: Interventional

This is a prospective, single-arm trial. The objective of the study is to determine the rate of atrial arrhythmia recurrence after pulmonary vein isolation (PVI) plus posterior wall isolation (PWI) using the Farawave PFA catheter in patients with longstanding persistent atrial fibrillation (AF). The trial will be conducted at as many as 10 US sites. Upon completion of site initiation, enrollment is expected to accrue at a rate of 10 patients per month. Total enrollment is expected to consist of 100 subjects. Accrual is expected to take 18 months, and all patients will be followed for 12 months post randomization. This study will be completed in 2 phases. There will be a 20 subject pilot phase, enrolled at one site (Mount Sinai). After completion of the pilot phase, the FDA will be provided with acute safety data (1 month). During the FDA's review of the pilot phase, enrollment may continue at the initial site. Also, IRB submissions at other prospective sites (up to a total of 10) may be initiated. Upon receipt of the go-ahead from FDA and after consultation with the study sponsor, the second phase of the study (to enroll 100 total subjects) will be performed. This research study currently has approval to enroll 25 patents. Should FDA grant approval to continue the study, the research team will expand as above and update this posting.

NCT ID: NCT06125925 Recruiting - Atrial Fibrillation Clinical Trials

Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.

NCT ID: NCT06124937 Recruiting - CABG Clinical Trials

Empagliflozin to Prevent Post-Operative Atrial Fibrillation

EMPOAF
Start date: November 7, 2023
Phase: Phase 3
Study type: Interventional

This is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. The goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2I), can reduce the incidence of post-operative atrial fibrillation and/or atrial flutter in patients with chronic coronary syndrome scheduled for isolated CABG. This trial will be conducted in two referral teaching cardiology hospitals in Tehran. 492 adult patients who are scheduled for elective isolated coronary artery bypass graft (CABG) surgery will be randomly assigned to one of the groups of intervention (empagliflozin 10 mg daily) or placebo starting 3 days before surgery until discharge.

NCT ID: NCT06124612 Recruiting - Atrial Fibrillation Clinical Trials

An Investigator-initiated Linked Study to OCEANIC-AF

Start date: November 3, 2023
Phase:
Study type: Observational

Impaired endogenous fibrinolysis is a recently recognised risk factor for thrombotic events in patients with cardiovascular disease. Enhancing endogenous fibrinolysis in such individuals represents a way of reducing thrombosis risk. However, the optimal pharmacotherapy to enhance fibrinolysis is unclear. The aim of this study is to assess the effect of asundexian on endogenous fibrinolysis and compare this to apixaban. If asundexian can enhance endogenous fibrinolysis, this could be used as targeted treatment for patients who despite optimal antithrombotic therapy, demonstrate impaired endogenous fibrinolysis.

NCT ID: NCT06119802 Recruiting - Atrial Fibrillation Clinical Trials

Prediction of UA/SOD Ratio as a Biomarker of Oxidative Stress in Atrial Fibrillation

Start date: January 1, 2022
Phase:
Study type: Observational

To clarify the predictive effects of uric acid and superoxide dismutase as biomarkers of oxidative stress on atrial fibrillation, and to provide greater value for the diagnosis and prediction of atrial fibrillation. It provides a new idea for the prevention and treatment of atrial fibrillation.