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EGM Analysis in Idiopathic Outflow Tract Ventricular Arrhythmia

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ClinicalTrials.gov Identifier: NCT02722577
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : July 29, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).

Condition or disease Intervention/treatment
Ventricular Outflow Tract Tachycardia Procedure: Radio-frequency Ablation

Detailed Description:
The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site During Idiopathic Outflow Tract Ventricular Arrhythmia Ablation
Actual Study Start Date : March 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Intervention Details:
  • Procedure: Radio-frequency Ablation
    A procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.


Primary Outcome Measures :
  1. Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery [ Time Frame: Intraoperative, an average of 2 hours ]


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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:   Non-Probability Sample
Study Population
20 patients meeting the inclusion and exclusion criteria
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo ablation for idiopathic OTVA
  • Have the ability to provide informed consent for study participation.

Exclusion Criteria:

  • Be currently participating in any other investigational study
  • Be less than 18 years of age
  • Be pregnant
  • Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)

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): NCT02722577


Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Guodong Niu, MD Fuwai Hospital
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02722577     History of Changes
Other Study ID Numbers: SJM-CIP-10090
First Posted: March 30, 2016    Key Record Dates
Results First Posted: July 29, 2019
Last Update Posted: August 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes