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

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

Summary

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)

Description

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.

OBJECTIVE:

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

Conditions

Atrial Fibrillation

Intervention

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

Location

Deutsches Herzzentrum Muenchen
Munich
Germany
80636

Status

Recruiting

Source

Deutsches Herzzentrum Muenchen

Results (where available)

View Results

Links

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

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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.

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