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

Completed

• Conditions: Phrenic Nerve Palsy

• Registration Number: NCT03645577
• Lead Sponsor: University of Luebeck

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-24
• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 731

Inclusion Criteria

• age 18 years or older
• Cryoballoon PVI
• Periprocedural phrenic lesion

Exclusion Criteria

• Non

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of phrenic nerve palsy	06/2012 until 04/2018	The overall incidence of phrenic nerve palsy during second and third Generation Cryoballoon based PVI will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Predictors of phrenic nerve palsy	06/2012 until 04/2018	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.
Clinical course of phrenic nerve palsy	06/2012 until 04/2018	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.

Trial Locations

Locations (1)

University Heart Center Luebeck, Electrophysiology; 🇩🇪 Luebeck, Germany