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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2021
Source University of Luebeck
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Heart Center Luebeck, Electrophysiology Luebeck

Sponsors (2)

Lead Sponsor Collaborator
University of Luebeck Principal Investigator: Roland Richard Tilz, MD

Country where clinical trial is conducted

Germany, 

Outcome

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
See also
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Completed NCT02893228 - Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block? Phase 4