Totally Endoscopic Ablation of Atrial Fibrillation

2014-08-27 03:20:46 | BioPortfolio


Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF.

Secondary Objectives

Does totally endoscopic ablation:

- reduce atrial fibrillation symptoms?

- increase working capacity and improve quality of life?

- improve atrial function?

- reduce the risk for stroke?


This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months.

After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test.

The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Atrial Fibrillation


Endoscopic ablation of AF, Rate control


Örebro University Hospital




University Hospital Orebro

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:20:46-0400

Clinical Trials [1135 Associated Clinical Trials listed on BioPortfolio]

Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) (HeartLight) in Patients With Paroxysmal Atrial Fibrillation (PAF)

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrill...

Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs

The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared ar...

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Ablation Versus Anti-Arrhythmic (AA) Drug Therapy for AF - Pivotal Trial

The CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hyp...

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pu...

PubMed Articles [19188 Associated PubMed Articles listed on BioPortfolio]

Catheter Ablation for "Lone" Atrial Fibrillation: Efficacy and Predictors of Recurrence.

Atrial fibrillation in otherwise healthy young patients has been termed "lone" atrial fibrillation (AF). The best treatment choice is still under discussion. The aim of this study was to report on eff...

Inter-atrial Conduction Time Can Predict New-onset Atrial Fibrillation After Radiofrequency Ablation of Isolated, Typical Atrial Flutter.

Many patients with successful atrial flutter (AFL) ablation will develop atrial fibrillation (AF) during follow-up. This study aimed to determine whether prolonged inter-atrial conduction time (IACT) ...

Current status of catheter ablation of atrial fibrillation in Japan: Summary of the 4th survey of the Japanese Catheter Ablation Registry of Atrial Fibrillation (J-CARAF).

The Japanese Heart Rhythm Society performs an annual survey, J-CARAF, to collect data on the atrial fibrillation (AF) ablation procedure, and requests its members to register data for AF ablation perf...

German Ablation Registry: Cryoballoon Versus RF Ablation in Paroxysmal Atrial Fibrillation - One Year Outcome Data.

Radiofrequency ablation has long been standard of care in atrial fibrillation (AF) ablation, cryoballoon technology has emerged a feasible approach with promising results. Prospective multicenter regi...

Direct left atrial ICE imaging guided ablation for atrial fibrillation without employing contrast medium.

Preoperative and intraoperative use of a contrast medium is unavoidable in catheter ablation for atrial fibrillation, which can become a particularly significant issue for patients suffering from rena...

Medical and Biotech [MESH] Definitions

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)

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).

Control of bleeding performed through the channel of the endoscope. Techniques include use of lasers, heater probes, bipolar electrocoagulation, and local injection. Endoscopic hemostasis is commonly used to treat bleeding esophageal and gastrointestinal varices and ulcers.

Fiberoptic endoscopy designed for duodenal observation and cannulation of VATER'S AMPULLA, in order to visualize the pancreatic and biliary duct system by retrograde injection of contrast media. Endoscopic (Vater) papillotomy (SPHINCTEROTOMY, ENDOSCOPIC) may be performed during this procedure.

An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.

More From BioPortfolio on "Totally Endoscopic Ablation of Atrial Fibrillation"

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'...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...