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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03645577

Acronym

YETI-Registry

Enrollment

731

Registered

2018-08-24

Start date

2018-07-24

Completion date

2019-11-30

Last updated

2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phrenic Nerve Palsy

Keywords

Pulmonary vein isolation, Phrenic nerve palsy, Paroxysmal atrial fibrillation, Persistent atrial fibrillation

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- Non

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Outcome results