Topics

Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device

2017-11-17 03:41:17 | BioPortfolio

Summary

This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and with contraindications to long-term oral antocoagulation therapy.

Description

Principal study aim: To document the impact of the next generation of Watchman LAAC device on key aspects of the implant procedure

Study Rationale: As an interventional procedure it is important that progressive steps are made to make the procedure safer, simpler, faster and more cost-effective. This study will document the impact of introducing the next generation of LAAC device, the Watchman FLX, into a clinical service. It is anticipated that the increased versatility of the Watchman FLX will lead to fewer repositionings and redeployments, shortening procedure time and reducing the mean number of devices opened per case.

Patients to be enrolled: Consecutive patients implanted with the Watchman FLX. All patients will meet current United Kingdom guidelines for LAAC, i.e. have atrial fibrillation, a high risk of thromboembolic stroke (CHA2DS2VASc score >2) and contraindications to long-term oral anticoagulation.

Study design: This is a prospective single-centre observational case-controlled study to be conducted at the John Radcliffe Hospital, Oxford, United Kingdom

Outcomes: Data collected will include patient demographics, left atrial appendage (LAA) dimensions and anatomical description, total procedure duration, device implant time (from introduction of Access sheath to cable release), number of devices opened/ used, number of repositions and redeployments, final position, presence of residual leak, acute complications, peri- and post-procedure antiplatelet and anticoagulant use and 6 week transesophageal echo findings. There will be a particular focus on the need for repositioning and redeployment and how that is undertaken (e.g. advancement of device distally into the LAA).

Timelines: For 20 patients in each group, 7 months from first patient enrolled to final patient undergoing 6 week transesophageal echo (TEE) followup will be required.

Study Design

Conditions

Atrial Fibrillation

Intervention

Left atrial appendage closure

Location

Department of Cardiology, John Radcliffe Hospital
Oxford
United Kingdom
OX3 9DU

Status

Withdrawn

Source

Oxford University Hospitals NHS Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-11-17T03:41:17-0500

Clinical Trials [1873 Associated Clinical Trials listed on BioPortfolio]

CLINICAL INVESTIGATION OF THE LAMBRETM LEFT ATRIAL APPENDAGE CLOSURE SYSTEM

The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or perm...

Canadian Left Atrial Appendage Closure Study

The purpose of the study is to demonstrate the safety and the rate of closure of the Ultrasept Left Atrial Appendage (LAA) Closure System for the percutaneous occlusion of the left atrial ...

Impact of Left Atrial Appendage Closure on Physical Capacity.

Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the b...

Left Atrium Appendage Closure by Surgery-2

Atrial fibrillation is a heart rhythm disorder that often occurs after heart surgery. During atrial fibrillation blood cloths may form, predominantly in the left atrial appendage, a small ...

Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO)

Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the device...

PubMed Articles [4236 Associated PubMed Articles listed on BioPortfolio]

Percutaneous Left Atrial Appendage Closure in Patients With Prior Intracranial Bleeding and Thromboembolism.

Percutaneous left atrial appendage closure (LAAC) is an alternative treatment in atrial fibrillation patients with contraindication to oral anticoagulation. Still, patient selection criteria for LAAC ...

Incidence and Causes of In-hospital Outcomes and 30-day Readmissions After Percutaneous Left Atrial Appendage Closure: A United States Nationwide Retrospective Cohort Study Using Claims Data.

Percutaneous left atrial appendage closure (p-LAAC) emerged as an option for stroke prevention in atrial fibrillation (AF) patients' ineligible for long-term anticoagulation.Real-world data on its in-...

Percutaneous left atrial appendage closure in a patient with atrial fibrillation and osler-weber-rendu disease

We present a case report of a 79-year-old woman with permanent atrial fibrillation and Osler-Weber-Rendu disease who underwent percutaneous closure of left atrial appendage. The patient had a history ...

Mapping and Localization of the Left Phrenic Nerve During Left Atrial Appendage Electrical Isolation to Avoid Inadvertent Injury in Patients Undergoing Catheter Ablation of Atrial Fibrillation.

A significant role of the left atrial appendage (LAA) in the genesis of atrial fibrillation (AF) has been described. LAA electrical isolation (LAAEI) confers substantial long-term clinical benefits. N...

2019 Chinese Society of Cardiology (CSC) expert consensus statement on left atrial appendage closure in the prevention of stroke in patients with atrial fibrillation.

Medical and Biotech [MESH] Definitions

Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).

Impaired or delayed impulse conduction between the right and left HEART ATRIA. Advanced interatrial blocks are often associated with arrhythmias (e.g., ATRIAL FLUTTER; and ATRIAL FIBRILLATION), direct conduction block via the Bachmann's bundle and concomitant left atrial enlargement. Syndrome of advanced interatrial block associated with SUPRAVENTRICULAR TACHYCARDIA is referred to as Bayes syndrome.

Long-term changes in the electrophysiological parameters and/or anatomical structures of the HEART ATRIA that result from prolonged changes in atrial rate, often associated with ATRIAL FIBRILLATION or long periods of intense EXERCISE.

Ear-shaped appendage of either atrium of the heart. (Dorland, 28th ed)

The pressure within the CARDIAC ATRIUM. It can be measured directly by using a pressure catheter (see HEART CATHETERIZATION). It can be also estimated using various imaging techniques or other pressure readings such as PULMONARY CAPILLARY WEDGE PRESSURE (an estimate of left atrial pressure) and CENTRAL VENOUS PRESSURE (an estimate of right atrial pressure).

More From BioPortfolio on "Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device"

Quick Search

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...


Searches Linking to this Trial