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Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon. (YETI-Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645577
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Principal Investigator: Roland Richard Tilz, MD
Information provided by (Responsible Party):
Christian-H. Heeger, MD, University of Luebeck

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

Condition or disease
Phrenic Nerve Palsy

Study Design
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Study Type : Observational
Actual Enrollment : 731 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics
Actual Study Start Date : July 24, 2018
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of phrenic nerve palsy [ Time Frame: 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 :
  1. Predictors of phrenic nerve palsy [ Time Frame: 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.

  2. Clinical course of phrenic nerve palsy [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who underwent a PVI by the second generation Cryoballoon.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Non

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645577


Locations
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Germany
University Heart Center Luebeck, Electrophysiology
Luebeck, Germany
Sponsors and Collaborators
University of Luebeck
Principal Investigator: Roland Richard Tilz, MD
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christian-H. Heeger, MD, PI, University of Luebeck
ClinicalTrials.gov Identifier: NCT03645577    
Other Study ID Numbers: 18-151A
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christian-H. Heeger, MD, University of Luebeck:
Pulmonary vein isolation
Phrenic nerve palsy
Paroxysmal atrial fibrillation
Persistent atrial fibrillation