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Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation

2014-08-27 03:19:37 | BioPortfolio

Summary

This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.

Description

Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.

An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.

This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Atrial Fibrillation

Intervention

Pulmonary vein cryoablation, Pulmonary vein radiofrequency ablation

Location

Unidad de Arritmias, Hospital Clínico San Carlos
Madrid
Spain
28040

Status

Recruiting

Source

Hospital San Carlos, Madrid

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:37-0400

Clinical Trials [4402 Associated Clinical Trials listed on BioPortfolio]

Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF

Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively t...

Comparison of Circumferential Pulmonary Vein Isolation and Complex Pulmonary Vein Isolation Additional Linear Ablation for Recurred Atrial Fibrillation After Previous Catheter Ablation: Prospective Randomized Trial (CALRA-AF)

The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for repeat ablation procedure among the patients with recurred atrial fibrillation aft...

Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

A three-pronged approach to evaluate long term success of non-paroxysmal ablation when using a: 1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compare...

Additional Linear Ablation Beyond Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Pulmonary vein(PV) isolation has become the cornerstone of radiofrequency ablation for AF. However, recent reports have clearly shown that the longer the follow-up period, the lower the su...

Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial

The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct ci...

PubMed Articles [4784 Associated PubMed Articles listed on BioPortfolio]

Pulmonary vein orientation is independently associated with outcomes following cryoballoon-based atrial fibrillation ablation.

Several studies have investigated the influence of pulmonary vein(PV) anatomy on outcomes of atrial fibrillation (AF) ablation. We aimed to evaluate the relationship between PV orientation and AF-free...

Pulmonary Vein Widening Plasty for Pulmonary Vein Stenosis and Occlusion After Catheter Ablation.

We successfully performed a pulmonary vein widening plasty in a patient with pulmonary vein stenosis and occlusion after multiple catheter ablations for paroxysmal atrial fibrillation.

Left atrial function after epicardial pulmonary vein isolation in patients with atrial fibrillation.

Epicardial pulmonary vein isolation has become an increasingly used therapy for medically resistant atrial fibrillation. The purpose of the present study was therefore to evaluate if epicardial pulmon...

Outcome in patients with left common pulmonary vein after cryoablation with second generation cryoballoon.

Pulmonary vein isolation (PVI) has become a widely accepted therapy in patients suffering from symptomatic atrial fibrillation (AF).

A preliminary study of pulmonary vein implant applicability and safety as a potential ablation platform in a follow-up study in Pigs.

Recurrence of atrial fibrillation after an ablation procedure remains a major problem which emphasizes the need for improved pulmonary vein isolation techniques.

Medical and Biotech [MESH] Definitions

Narrowing of the PULMONARY VEIN.

Placement of a balloon-tipped catheter into the pulmonary artery through the antecubital, subclavian, and sometimes the femoral vein. It is used to measure pulmonary artery pressure and pulmonary artery wedge pressure which reflects left atrial pressure and left ventricular end-diastolic pressure. The catheter is threaded into the right atrium, the balloon is inflated and the catheter follows the blood flow through the tricuspid valve into the right ventricle and out into the pulmonary artery.

An anomalous pulmonary venous return in which the right PULMONARY VEIN is not connected to the LEFT ATRIUM but to the INFERIOR VENA CAVA. Scimitar syndrome is named for the crescent- or Turkish sword-like shadow in the chest radiography and is often associated with hypoplasia of the right lung and right pulmonary artery, and dextroposition of the heart.

A malformation of the heart in which the embryonic common PULMONARY VEIN was not incorporated into the LEFT ATRIUM leaving behind a perforated fibromuscular membrane bisecting the left atrium, a three-atrium heart. The opening between the two left atrium sections determines the degree of obstruction to pulmonary venous return, pulmonary venous and pulmonary arterial hypertension.

A short thick vein formed by union of the superior mesenteric vein and the splenic vein.

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