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Atrial Fibrillation clinical trials

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NCT ID: NCT03827915 Recruiting - Atrial Fibrillation Clinical Trials

Double Sequential External Defibrillation in Patients With Atrial Fibrillation Refractory to DC Cardioversion

Start date: January 21, 2019
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a common cardiac arrhythmia that leads to increased risk of heart failure, hospitalization, thromboembolic events, and death. Restoration of normal heart rhythm is performed in many patients with AF to improve symptoms. In this study, the investigators will consider patients who fail 2 or more trials of DC cardioversion as having refractory AF. The aim of this study is to assess whether the use of double sequential defibrillation in patients with refractory AF has a higher success rate in reverting them to a normal heart rhythm than a third cardioversion. This is a phase III, randomized controlled, single-centered, superiority trial. All patients with AF admitted to the coronary care unit (CCU) for DC cardioversion, and refractory to at least two trials of DC cardioversion will be enrolled. Patients are randomized into two arms: the first will receive a third trial of DC cardioversion (standard of care) and the second will receive double sequential external defibrillation. The resolution of AF by reverting back to normal sinus rhythm is the primary outcome of the investigators. This will be determined using EKG (electrocardiogram) immediately after DC cardioversion or double sequential defibrillation.

NCT ID: NCT03821883 Recruiting - Stroke Clinical Trials

Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation

ASPIRIN-LAAO
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appendage occlusion (LAAO). Patients diagnosed with atrial fibrillation and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment. The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

NCT ID: NCT03818724 Recruiting - Clinical trials for Cardiovascular Diseases

Treatment Success With the CoolLoop Cryoablation System

Start date: January 17, 2019
Phase:
Study type: Observational [Patient Registry]

This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop® cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of 36 months. A further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.

NCT ID: NCT03816865 Recruiting - Stroke Clinical Trials

Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

NOR-FIB2
Start date: March 1, 2018
Phase:
Study type: Observational

Protocol synopsis Sponsor: Oslo University Hospital Title: Fibrosis, inflammation and cerebral infarction in patients with atrial fibrillation Study Design: The study is an observational prospective study of atrial fibrillation patients undergoing direct-current cardioversion. Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic lesions after programmed direct-current cardioversion using diffusion-weighted sequences in brain MRI (DWMRI). Secondary Objectives: To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF. To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF. To assess cognitive and cerebral structural and metabolic changes after direct-current cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before and 12 months after treatment. Number of Subjects: 50 Study Centers: Østfold Hospital Trust Duration of Study Participation: - Enrollment: 18 months - Follow-up period: 12 months - Total Study Duration: 30 months Primary Endpoints: • Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion. Secondary Endpoints: - Rate of AF recurrence within 1 year after direct current cardioversion - Change in levels of inflammation biomarkersfrom baseline to 12 months follow-up - Change in levels of fibrosis biomarkers from baseline to 12 months follow-up - Cognitive function at 12 months follow-up - Changes in uptake pattern on cerebral 18F-FDG-PET from baseline to 12 months follow-up - Changes in uptake pattern on cardiac 18F-FDG-PET from baseline to 12 months follow-up - Brain volume at 12 months follow-up - White matter volume 12 months follow-up - Grey matter volume 12 months follow-up - Cortical volume 12 months follow-up - RSI-derived diffusion parameters 12 months follow-up: fast apparent diffusion coefficient, extracellular water fraction, fractional anisotropy; free water fraction; intracranial volume; NAWM: normal appearing white matter; neurite density; RSI: restriction spectrum imaging; sADC: slow apparent diffusion coefficient;restricted fractional anisotropy; white matter lesions.

NCT ID: NCT03816033 Recruiting - Atrial Fibrillation Clinical Trials

Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

A program of research has been set up at St. George's Hospital, London studyng the practicalities of catheter ablation. The current practice of catheter ablation is being studied for a range of arrhythmias including PAF, persistent AF, advanced persistent AF and resistant WPW.

NCT ID: NCT03811938 Recruiting - Clinical trials for Persistent Atrial Fibrillation

Ablation of Low Voltage Regions in Persistent Atrial Fibrillation

ABLOVO-AF
Start date: August 24, 2017
Phase: N/A
Study type: Interventional

Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofrequency ablation (RFA). This technology works by heating heart muscle inside the heart to break the electrical circuits responsible for the abnormal rhythm. The energy is delivered into the heart with plastic tubes that have metal electrodes, inserted through the groin veins and removed after the procedure. The patient is usually put to sleep during the intervention. If the AF has been present for more than seven days but for less than one year it is called persistent, and it can be difficult to treat successfully with the usual methods. Goals. The study will test a new RFA technique to treat patients with persistent AF. This involves identifying areas within the left upper chamber that have a lower electrical voltage than the surrounding heart muscle and applying RFA to the border zones of these areas. Methods. The new technology combined with the usual procedure will be compared to the usual procedure alone. All patients will receive ablation according to the new technique and results will be compared to a historical control group from the trial institution. Follow up. Patients will be followed up for 12 months with clinic visits and heart rhythm checks. Potential benefit. The new technique will be assessed for success at keeping patients free from persistent AF compared to the usual methods. The study will be performed at Imperial College Healthcare NHS Trust, at the Hammersmith Hospital. Licensed clinical software will be used from St Jude Medical to guide ablation and a special research software module will be used to analyse data from the heart following ablation. The study will be sponsored by Imperial College Healthcare NHS Trust

NCT ID: NCT03811795 Recruiting - Atrial Fibrillation Clinical Trials

Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib

Start date: November 27, 2018
Phase: N/A
Study type: Interventional

The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform repeat ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation.

NCT ID: NCT03793465 Recruiting - Clinical trials for Post-operative Atrial Fibrillation (POAF)

Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Start date: February 8, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue.

NCT ID: NCT03789695 Recruiting - Atrial Fibrillation Clinical Trials

RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD

RE-ELECT
Start date: November 14, 2018
Phase: Phase 4
Study type: Interventional

Kidney function in patients with atrial fibrillation (AF) is tending to decline over a time which is clearly demonstrated in clinical studies. Renal impairment is a risk factor for stroke, its progression is associated with unfavorable prognosis. So preserving kidney function should be considered as a one of priorities when choosing treatment strategies which is especially important in patients with existing chronic kidney disease (CKD) or in patients who have risk of its development. This is especially relevant for the patients with type 2 diabetes mellitus (T2DM) and with CKD who can be considered as a group of risk for rapid kidney function decline.

NCT ID: NCT03788941 Recruiting - Atrial Fibrillation Clinical Trials

Left Atrial Appendage Closure in Combination With Catheter Ablation

LAACablation
Start date: January 1, 2017
Phase:
Study type: Observational

This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.