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

NCT ID: NCT03645577

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

731 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-24

Study Completion Date

2019-11-30

Brief Summary

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

Detailed Description

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Conditions

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Phrenic Nerve Palsy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Non
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Principal Investigator: Roland Richard Tilz, MD

UNKNOWN

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Christian-H. Heeger, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Heart Center Luebeck, Electrophysiology

Lübeck, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36414239 (View on PubMed)

Heeger 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.

Reference Type DERIVED
PMID: 34962134 (View on PubMed)

Other Identifiers

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18-151A

Identifier Type: -

Identifier Source: org_study_id

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