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

Phrenic Nerve Palsy Clinical Trial

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Official title:

Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645577
• Other study ID #: 18-151A
• Status: Completed
• Start date: July 24, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: January 2021
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non

Related Conditions & MeSH terms

• Phrenic Nerve Palsy

Locations

Country	Name	City	State
Germany	University Heart Center Luebeck, Electrophysiology	Luebeck

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	Principal Investigator: Roland Richard Tilz, MD

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of phrenic nerve palsy	The overall incidence of phrenic nerve palsy during second and third Generation Cryoballoon based PVI will be evaluated.	06/2012 until 04/2018
Secondary	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.	06/2012 until 04/2018
Secondary	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.	06/2012 until 04/2018