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Atrial Fibrillation, Persistent clinical trials

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NCT ID: NCT05993104 Withdrawn - Atrial Fibrillation Clinical Trials

Shape vs Substrate in AF

Start date: January 2024
Phase:
Study type: Observational

Atrial fibrillation (AF) is an abnormal heart rhythm which originates from the top two chambers (atria) of the heart. It can cause significant symptoms and have severe consequences such as stroke. Catheter ablation is a treatment for AF. It is minimally invasive, involving thin tubes known as catheters, being inserted through a blood vessel in the groin and passed to the heart under X-ray guidance. Once in the heart, regions of tissue believed responsible for the abnormal heart rhythm can be identified, and hot or cold energy used to create scar at these areas, preventing the abnormal rhythm. Identifying these regions is a key challenge in making the treatment as effective as possible. The investigators believe that there may be a change in the shape of a participant's atria in these regions and as such identifying and treating areas of abnormal shape may be beneficial. To investigate this, the study team propose three phases. The first, uses previously collected data to make a model of what is average atrial geometry in AF. Investigators will then compare individual participants' atrial geometries to this average shape to identify areas of geometric abnormality and see how these correspond to areas of abnormal electrical activity. In the second phase, investigators will collect new data on how much atrial geometry changes during catheter ablation procedures. Finally, in the third phase, investigators will investigate whether including geometric assessment in the catheter ablation procedure is feasible from a work flow perspective.

NCT ID: NCT05944575 Not yet recruiting - Clinical trials for Atrial Fibrillation, Persistent

Effect of taVNS on Heart Rate in Persistent Atrial Fibrillation

Start date: August 7, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effects of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in patients with persistent atrial fibrillation. taVNS is a treatment through which a small electrical current is applied to a specific location of the left ear. The main question to answer is whether taVNS will reduce the heart rate in patients with persistent atrial fibrillation. After appropriate training, participants will self-administer taVNS for 30 minutes every day for two weeks. During one of the two weeks (randomized order), the clip electrode, delivering the electrical current will be attached to the cymba conchae of the left ear, while during the other week the clip electrode will be attached to the lobule of the left ear. During both weeks, the electrocardiogram (ECG) will be monitored continuously through a small ECG patch that is placed on the chest. Participants will meet with the investigators at the beginning of the study, after 7 days and at the end of the study (after 14 days). Researchers will compare the ECG obtained during the two weeks and evaluate if the heart rate differs between the two study weeks.

NCT ID: NCT05939076 Not yet recruiting - Clinical trials for Atrial Fibrillation, Persistent

First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation

Start date: August 21, 2023
Phase: Phase 3
Study type: Interventional

The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are: - Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting > 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF? - Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF/AT burden, AF/AT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular; - Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor, - Regular echocardiographic exams for reverse atrial remodelling assessment, - HRQoL questionnaires - Assessment of cognitive function - Atrial fibrillation evaluation regarding structured characterisation and AF progression/regression - Assessment of Health care use and costs - Safety

NCT ID: NCT05883722 Not yet recruiting - Clinical trials for Atrial Fibrillation, Persistent

Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

Start date: June 30, 2023
Phase: N/A
Study type: Interventional

Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

NCT ID: NCT05883631 Recruiting - Atrial Fibrillation Clinical Trials

RESOLVE-AF: Clinical Evaluation of the Ablacathâ„¢ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

RESOLVE-AF
Start date: October 23, 2023
Phase: N/A
Study type: Interventional

Demonstrate the safety and effectiveness of the Ablacathâ„¢ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.

NCT ID: NCT05870306 Active, not recruiting - Clinical trials for Atrial Fibrillation, Persistent

Triple Atria Extrastimuli vs Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The problem addressed in this proposal is related to the success rate in treating one of the most common arrhythmias in the Western population, atrial fibrillation (AF). Specifically, the success rate is particularly low in persistent atrial fibrillation, being up to 40% lower than the success rate for paroxysmal atrial fibrillation. Atrial fibrillation is associated with increased mortality and morbidity (stroke, heart failure, dementia, etc.). The most effective treatment is electrical isolation of the pulmonary veins (PVI) by catheter ablation using radiofrequency or cryoablation of the atrial myocardial tissue. This ablation allows the elimination of the main initiators of the arrhythmia but may not address its maintainers, which play a significant role in persistent atrial fibrillation. This project proposes a new approach in studying the atrial myocardial substrate for persistent fibrillation ablation. Until now, maintainers of the arrhythmia have been sought by conducting studies during atrial fibrillation. In this project, we will use short-coupled stimulation techniques during sinus rhythm and analyze the response of the atrial myocardium, attempting to unmask areas where the impulse propagates abnormally/slowly. These areas of the atrial muscle with hidden slow conduction (HSC) could generate short circuits that maintain atrial fibrillation. It would be expected that these areas would show fragmented electrograms in response to rapid electrical stimuli not visible in basal rhythm. The study is divided into two sub-studies to be carried out over the 3-year project. 1. This study aims to test the feasibility of this new arrhythmic substrate characterization strategy, as well as observe differences between patients with paroxysmal and persistent AF and compare it with conventional fragmented electrogram analysis during AF. 2. The second sub-study will apply the knowledge acquired during the first phase regarding the characterization of electrograms-HSC, allowing for radiofrequency ablation procedures to be performed using a new substrate ablation technique consisting of the elimination of these electrograms and comparing the results with those patients who undergo conventional pulmonary vein ablation techniques. The ultimate goal, from a global point of view, is to demonstrate that it is possible to improve the results of arrhythmia treatment by identifying and eliminating these electrograms-HSC.

NCT ID: NCT05749107 Recruiting - Clinical trials for Atrial Fibrillation, Persistent

In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation

ASTRA
Start date: December 2, 2022
Phase:
Study type: Observational [Patient Registry]

1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry. The project will aim to 1. assess the prevalence of moderate/severe isolated STR in patients with AF; 2. identify the mechanisms associated with the development of moderate-severe STR in patients with AF; 3. identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderate/severe STR; 4. evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures (i.e. right ventricle, right atrium, and tricuspid valve apparatus).

NCT ID: NCT05575557 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular block or sick sinus syndrome, but in fact such pacing could cause ventricular asynchrony, which could lead to long-term myocardial perfusion injury, valvular regurgitation, heart failure, and increased risk of ventricular tachycardia and ventricular fibrillation. The latest guideline recommended reducing the proportion of right ventricular pacing. Additionally, in patients with heart failure with reduced ejection fraction (EF ≤ 35%) and complete left bundle branch block, cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) has been recommended to improve cardiac function, but only about 30% of patients benefit from it, which may be related to poor left ventricular pacing site and myocardial scarring. In theory, His bundle pacing (HBP) compared with RVP can reduce the risk of functional tricuspid regurgitation when the lead position lies on the atrial side of the tricuspid valve, which may improve the right heart function and pulmonary artery pressure. In 2021, Domenico Grieco et al. explored the effect of HBP on right heart function. After 6 months of follow-up, it was found that HBP improved right heart function and pulmonary artery pressure compared with RVP. At present, there are few discussions on the effect of physiological pacing on right ventricular hemodynamics, and the sample size is small. Internationally, the discussion of the assessment of hemodynamics is limited to non-invasive evaluation (such as echocardiography, ECG, SPECT) The gold standard for right heart hemodynamics evaluation is the measurement of invasive right heart catheterization, and there has been no relevant research so far, so the investigators further designed a study of the effect of physiological pacing on hemodynamics.

NCT ID: NCT05507749 Active, not recruiting - Clinical trials for Atrial Fibrillation, Persistent

Cyroablation for Pulmonary Vein Isolation Alone in Patients With Early Persistent AF Assessed by Continuous Monitoring

COOL-PER
Start date: November 27, 2020
Phase: N/A
Study type: Interventional

This study aimed to evaluate the efficacy of Cryoablation in patients with early persistent atrial fibrillation as a first index procedure using continuous cardiac rhythm monitoring.

NCT ID: NCT05481359 Active, not recruiting - Clinical trials for Cardiovascular Diseases

AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.

Start date: September 12, 2022
Phase:
Study type: Observational [Patient Registry]

This post-market global registry will evaluate the ability of the Ablamap® Software to identify atrial fibrillation sources and guide ablation therapy in patients with atrial fibrillation.