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OpenTrials
Completed

NCT Number: NCT03645577

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

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

Completed

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Key information

Conditions

Phrenic Nerve Palsy Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heart Center Luebeck, Electrophysiology

Lübeck, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • Principal Investigator: Roland Richard Tilz, MD

Registry information

Official study title

Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics

Acronym: YETI-Registry

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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