- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645577
Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon. (YETI-Registry)
January 28, 2021 updated by: Christian-H. Heeger, MD, University of Luebeck
Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics
To determine the most frequent complication associated with cryoballoon PVI.
The main hypothesis is to explore the incidence of phrenic nerve palsy.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
731
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Luebeck, Germany
- University Heart Center Luebeck, Electrophysiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients who underwent a PVI by the second generation Cryoballoon.
Description
Inclusion Criteria:
- age 18 years or older
- Cryoballoon PVI
- Periprocedural phrenic lesion
Exclusion Criteria:
- Non
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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06/2012 until 04/2018
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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06/2012 until 04/2018
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Clinical course of phrenic nerve palsy
Time Frame: 06/2012 until 04/2018
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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.
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06/2012 until 04/2018
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2018
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
July 26, 2018
First Submitted That Met QC Criteria
August 22, 2018
First Posted (Actual)
August 24, 2018
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-151A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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