Pulmonary Vein (PV) -Isolation: Arrhythmogenic Vein(s) Versus All Veins

2014-07-24 14:19:01 | BioPortfolio


We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of the arrhythmogenic pulmonary vein(s)


BACKGROUND Atrial fibrillation ablation procedures typically involve isolation of all pulmonary veins (PVs), yet the need for such an extensive ablation strategy in all patients is unclear.


We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of only the arrhythmogenic pulmonary vein(s). The single-blind interventional, randomized study will include 106 patients in each arm.

A reablation procedure, with the use of the same technique as the first ablation, will be offered to the patient in case of a symptomatic atrial fibrillation recurrence beyond the third month after the ablation procedure.

Follow-Up After discharge, patients w ill be scheduled for repeated visits in the arrhythmia clinic at 3 and 6 months after the first ablation. At each of these visits, intensive questioning for arrhythmia-related symptoms (fatigue, dizziness, and nausea) since the last follow-up visit was performed, especially for those that the patient had experienced before ablation. At every follow-up visit, 7-day Holter monitoring w ill be performed. Multislice CT or MRI of the pulmonary vein w ill be obtained before and 3 months after the ablation procedure for evaluation of the pulmonary vein anatomy and for detection of radiofrequency ablation-induced pulmonary vein stenosis .

Study End Points and Definitions The primary end point of the study will be freedom from atrial tachyarrhythmias (of > 30-second duration) including atrial fibrillation and atypical atrial flutter documented by 7-day Holter monitoring performed at the 6-month follow-up. Two secondary study end points will be chosen. The first will be freedom from arrhythmia-related symptoms during the 6-month follow-up. Because early recurrences of atrial tachyarrhythmias within the first month after ablation may be a transient phenomenon, this time interval was excluded from analysis. Second, a composite of periprocedural pericardial tamponade, thromboembolic complications, and pulmonary vein stenosis with > 50% lumen loss (main vessel or first branching) was defined as a safety end point

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Atrial Fibrillation


Segmental PV-Isolation of the arrhythmogenic vein(s), Segmental PV-Isolation of all veins


Deutsches Herzzentrum Muenchen




Deutsches Herzzentrum Muenchen

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T14:19:01-0400

Clinical Trials [1207 Associated Clinical Trials listed on BioPortfolio]

PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-Inferiority Trial (FreezeAF)

This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be ...

MARSHALL PLAN Vs. Pulmonary Veins Isolation Monocentric Trial

In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhy...

Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysma...

Radiofrequency vs Cryoballoon Ablation for Atrial Fibrillation Assessed by Implantable Cardiac Monitor

The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryob...

Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation

Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus l...

PubMed Articles [3203 Associated PubMed Articles listed on BioPortfolio]

Safety and efficacy outcomes of left atrial posterior wall isolation compared to pulmonary vein isolation and pulmonary vein isolation with linear ablation for the treatment of persistent atrial fibrillation.

Pulmonary wall isolation (PWI) is increasingly used as an adjunctive lesion set to compliment pulmonary vein isolation (PVI), especially in patients with persistent atrial fibrillation (AF). The objec...

Amplified sinus-P-wave reveals localization and extent of left atrial low-voltage substrate: implications for arrhythmia freedom following pulmonary vein isolation.

Presence of arrhythmogenic left atrial (LA) low-voltage substrate (LVS) is associated with reduced arthythmia freedom rates following pulmonary vein isolation (PVI) in persistent atrial fibrillation (...

Can the Durability of Pulmonary Vein Isolation be Predicted by the Time-to-Isolation in Second-generation Cryoballoon Ablation? Insight from the Results of Repeat Procedures.

Second-generation cryoballoons (2-CBs) are widely used in atrial fibrillation (AF) ablation, however, the optimal freeze dose is still under debate. Recently, the time-to-isolation (TTI), which is the...

Translational anatomy of the left atrium and esophagus as relevant to the pulmonary vein antral isolation for atrial fibrillation.

Pulmonary vein antrum isolation by radiofrequency ablation has become a preferred treatment for atrial fibrillation. The aim of our research is to study the anatomy of the PVantrum and its related str...

Significance of inducibility of atrial fibrillation after pulmonary vein isolation in patients with healthy left atrium substrate.

The significance of inducibility of atrial fibrillation (AF) after pulmonary vein isolation (PVI) in patients with AF remains disputable and polarizing. Therefore, we investigated the prognostic value...

Medical and Biotech [MESH] Definitions

Veins which return blood from the intestines; the inferior mesenteric vein empties into the splenic vein, the superior mesenteric vein joins the splenic vein to form the portal vein.

A clinicopathological syndrome or diagnostic term for a type of glomerular injury that has multiple causes, primary or secondary. Clinical features include PROTEINURIA, reduced GLOMERULAR FILTRATION RATE, and EDEMA. Kidney biopsy initially indicates focal segmental glomerular consolidation (hyalinosis) or scarring which can progress to globally sclerotic glomeruli leading to eventual KIDNEY FAILURE.

The segregation of patients with communicable or other diseases for a specified time. Isolation may be strict, in which movement and social contacts are limited; modified, where an effort to control specified aspects of care is made in order to prevent cross infection; or reverse, where the patient is secluded in a controlled or germ-free environment in order to protect him or her from cross infection.

Restriction of freedom of movement of individuals who have been exposed to infectious or communicable disease in order to prevent its spread; a period of detention of vessels, vehicles, or travelers coming from infected or suspected places; and detention or isolation on account of suspected contagion. It includes government regulations on the detention of animals at frontiers or ports of entrance for the prevention of infectious disease, through a period of isolation before being allowed to enter a country. (From Dorland, 28th ed & Black's Veterinary Dictionary, 17th ed)

The vein formed by the union of the anterior and posterior tibial veins; it courses through the popliteal space and becomes the femoral vein.

More From BioPortfolio on "Pulmonary Vein (PV) -Isolation: Arrhythmogenic Vein(s) Versus All Veins"

Quick Search

Relevant Topics

Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Searches Linking to this Trial