Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon.
YETI-Registry
1 other identifier
observational
731
1 country
1
Brief Summary
To determine the most frequent complication associated with cryoballoon PVI. The main hypothesis is to explore the incidence of phrenic nerve palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2018
CompletedFirst Submitted
Initial submission to the registry
July 26, 2018
CompletedFirst Posted
Study publicly available on registry
August 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedJanuary 29, 2021
January 1, 2021
1.4 years
July 26, 2018
January 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Predictors of phrenic nerve palsy
06/2012 until 04/2018
Clinical course of phrenic nerve palsy
06/2012 until 04/2018
Eligibility Criteria
All patients who underwent a PVI by the second generation Cryoballoon.
You may qualify if:
- age 18 years or older
- Cryoballoon PVI
- Periprocedural phrenic lesion
You may not qualify if:
- \- Non
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Heart Center Luebeck, Electrophysiology
Lübeck, Germany
Related Publications (2)
Heeger CH, Popescu SS, Sohns C, Pott A, Metzner A, Inaba O, Straube F, Kuniss M, Aryana A, Miyazaki S, Cay S, Ehrlich JR, El-Battrawy I, Martinek M, Saguner AM, Tscholl V, Yalin K, Lyan E, Su W, Papiashvili G, Botros MSN, Gasperetti A, Proietti R, Wissner E, Scherr D, Kamioka M, Makimoto H, Urushida T, Aksu T, Chun JKR, Aytemir K, Jedrzejczyk-Patej E, Kuck KH, Dahme T, Steven D, Sommer P, Tilz RR. Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis. Europace. 2023 Feb 16;25(2):374-381. doi: 10.1093/europace/euac212.
PMID: 36414239DERIVEDHeeger CH, Sohns C, Pott A, Metzner A, Inaba O, Straube F, Kuniss M, Aryana A, Miyazaki S, Cay S, Ehrlich JR, El-Battrawy I, Martinek M, Saguner AM, Tscholl V, Yalin K, Lyan E, Su W, Papiashvili G, Botros MSN, Gasperetti A, Proietti R, Wissner E, Scherr D, Kamioka M, Makimoto H, Urushida T, Aksu T, Chun JKR, Aytemir K, Jedrzejczyk-Patej E, Kuck KH, Dahme T, Steven D, Sommer P, Richard Tilz R. Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry. Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010516. doi: 10.1161/CIRCEP.121.010516. Epub 2021 Dec 28.
PMID: 34962134DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
July 26, 2018
First Posted
August 24, 2018
Study Start
July 24, 2018
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
January 29, 2021
Record last verified: 2021-01