Phrenic Nerve Palsy Clinical Trial
— YETI-RegistryOfficial title:
Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics
NCT number | NCT03645577 |
Other study ID # | 18-151A |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 24, 2018 |
Est. completion date | November 30, 2019 |
Verified date | January 2021 |
Source | University of Luebeck |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To determine the most frequent complication associated with cryoballoon PVI. The main hypothesis is to explore the incidence of phrenic nerve palsy.
Status | Completed |
Enrollment | 731 |
Est. completion date | November 30, 2019 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age 18 years or older - Cryoballoon PVI - Periprocedural phrenic lesion Exclusion Criteria: - Non |
Country | Name | City | State |
---|---|---|---|
Germany | University Heart Center Luebeck, Electrophysiology | Luebeck |
Lead Sponsor | Collaborator |
---|---|
University of Luebeck | Principal Investigator: Roland Richard Tilz, MD |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Predictors of phrenic nerve palsy | 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. | 06/2012 until 04/2018 | |
Secondary | Clinical course of phrenic nerve palsy | 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. | 06/2012 until 04/2018 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?
|
Phase 4 |