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Atrial Flutter clinical trials

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NCT ID: NCT04738071 Active, not recruiting - Stroke Clinical Trials

International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

IMPROVE
Start date: November 13, 2019
Phase:
Study type: Observational [Patient Registry]

Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally. The IMPROVE (International Multicenter Patent foRamen OVale & strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries. The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.

NCT ID: NCT04678258 Recruiting - Radiation Exposure Clinical Trials

Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

ZERO MAGIC
Start date: November 30, 2020
Phase: N/A
Study type: Interventional

Catheter ablation of the cavo-tricuspid isthmus (CTI) is the curative first-line therapy for typical atrial flutter. Currently, two approaches are used in clinical practice. In contrast to the conventional linear ablation approach, the Maximum voltage-guided (MVG) strategy aims to limit ablation to high voltage areas (HVAs) representing the detectable correlate of relevant conducting bundles. Data from registries show that the MVG technique is sufficient to reach comparable clinical outcome with significantly shorter ablation duration when compared to the conventional linear strategy. Despite growing evidence, however, data from properly powered prospective randomized trials are lacking and the linear approach still remains standard. In addition, data on radiation exposure are controversial. As a substrate-based approach, the MVG strategy requires detailed mapping and signal analysis for identification of the individual architecture and exactly targeted energy application. However, the spatial mapping resolution of large tip catheters is limited. The use of the MicroFidelity catheter technology (IntellaMiFi) with high resolution mini-electrodes at the 8 mm catheter tip can be expected to further improve the feasibility of a voltage-guided approach. In addition, the MVG approach theoretically may encompass an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is needed to further evaluate this issue. Objective of this prospective randomized study is evaluate the performance of the micro-sensor technology for zero-fluoroscopy voltage-guided ablation of typical atrial flutter (AFL) compared with a population undergoing conventional linear ablation including a predefined invasive re-evaluation of persistent CTI block in addition to clinical follow-up. The study has been approved by the responsible ethics committee.

NCT ID: NCT04658940 Completed - Clinical trials for Typical Atrial Flutter

AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)

AcQForce AFL
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.

NCT ID: NCT04657055 Recruiting - Clinical trials for Typical Atrial Flutter

AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU)

AFL-EU
Start date: April 23, 2021
Phase: N/A
Study type: Interventional

The Acutus Medical AcQForce Flutter-EU clinical study is a prospective, multi-center, non-randomized global study designed to confirm the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter. The AcQForce Flutter-EU study is a post-market study that will be run in parallel with a US IDE study of similar design. Data will be combined to support a pre-market approval (PMA) application to the US Food and Drug Administration (FDA).

NCT ID: NCT04645342 Completed - Atrial Fibrillation Clinical Trials

Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

WIRE-IT
Start date: November 30, 2020
Phase: N/A
Study type: Interventional

This is a randomized controlled trial examining whether Baylis's Versacross RF wire versus the conventional Baylis RF needle is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by time to successful transseptal puncture, during cardiac ablation procedures.

NCT ID: NCT04632641 Completed - Atrial Fibrillation Clinical Trials

Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial

SAFE-VEIN
Start date: April 23, 2021
Phase: N/A
Study type: Interventional

Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.

NCT ID: NCT04593498 Recruiting - Atrial Fibrillation Clinical Trials

Excessive Supraventricular Activity and Atrial Fibrillation

ESA-AF
Start date: November 1, 2022
Phase:
Study type: Observational

The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.

NCT ID: NCT04545437 Recruiting - Stroke Clinical Trials

The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study

C3
Start date: August 10, 2020
Phase:
Study type: Observational

The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.

NCT ID: NCT04512222 Recruiting - Atrial Fibrillation Clinical Trials

EARLY-MYO-AF Registry

Start date: January 1, 2012
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to depict the myocardial function improvement in AF patients by integrated therapy and to assess the prognostic discrepancies of various intervention modalities. Information will be collected prospectively in about 5000 AF patients. Subjects will be followed for up to 3 years.

NCT ID: NCT04473495 Not yet recruiting - Clinical trials for Coronary Artery Disease

The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.

VATIC
Start date: August 2020
Phase:
Study type: Observational

This study evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention