Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon.

University of Luebeck731 enrolled

Overview

To determine the most frequent complication associated with cryoballoon PVI. The main hypothesis is to explore the incidence of phrenic nerve palsy.

Study Type

OBSERVATIONAL

Enrollment

731

Conditions

Phrenic Nerve Palsy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 18 years or older * Cryoballoon PVI * Periprocedural phrenic lesion Exclusion Criteria: \- Non

Locations (1)

University Heart Center Luebeck, Electrophysiology

Lübeck, Germany

Outcomes

Primary Outcomes

Incidence of phrenic nerve palsy

The overall incidence of phrenic nerve palsy during second and third Generation Cryoballoon based PVI will be evaluated.

Time frame: 06/2012 until 04/2018

Secondary Outcomes

Predictors of phrenic nerve palsy

Predictors for transient and permanent phrenic nerve palsy will be evaluated. For this purpose baseline characteristics (e.g. age, sex, BMI, CHADS-VASc-Score) as well as periprocedural data (e.g. minimal cryoballoon temp., cryoballoon temp. after 30 seconds, time to isolation, PV diameter, use of doublestopp technique and draw back manouever) will be assesseda and predictors will be calculated using adequat statistical techniques.

Time frame: 06/2012 until 04/2018

Clinical course of phrenic nerve palsy

The clincial course of phrenic nerve palsy after second and third Generation Cryoballoon based PVI will be evaluated by follow-up appointments according to each centers standard of care. For this purpose follow-up data will be evaluated and the clinical course will be assessed.

Time frame: 06/2012 until 04/2018

Data from ClinicalTrials.gov

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