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Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114124
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The aim of our study is to investigate the comparative efficacy of high fidelity multi electrode ablation catheters vs the standard bipolar configuration in success of AV nodal ablation This study will provide insights on the use of new technology where application may increase efficacy, promote patient and physician safety and decrease costs.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: MIFI Catheter Device: Standard Ablation Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Standard ablation catheter vs MIFI catheter
Masking: Single (Investigator)
Masking Description: Variable block sizes will be used to improve the blinding of the clinical team. This information will then be used to design a fully-powered randomized study to compare these two arms. Patients will be randomly assigned to study arms. The project biostatistician and team will generate a set of envelopes which contain the random assignments for each patient. Once a patient has consented to participate, the next envelope will be opened for that patient and the catheter assignment will be revealed. This will maintain the blinding of the clinical team.
Primary Purpose: Treatment
Official Title: Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation A Comparative Pilot Study of Time to Success
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : November 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bipolar Ablation Catheter
Subjects will be randomized by random computer programming to receive standard ablation catheter for their procedure.
Device: Standard Ablation Catheter
Standard of care for patients with certain cardiac arrhythmias.

Experimental: MIFI Ablation Catheter
Subjects will be randomized by random computer programming to receive an ablation with MIFI technology. MIFI Catheter contains tightly spaced multielectrode pattern
Device: MIFI Catheter
Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity




Primary Outcome Measures :
  1. The time differences between the 2 arms for acute success of ablation identified by a junctional rhythm or complete heart block [ Time Frame: 60 minutes ]
    Identified by a junctional rhythm or complete heart block. Time zero is when the ablation procedure begins and the successful outcomes are either complete heart block or junctional rhythm. Assessed in minutes


Secondary Outcome Measures :
  1. The total time differences between the 2 arms for the entire procedure time [ Time Frame: 60 minutes ]
    The time from when the catheter enters the heart the time the procedure is stopped. Assessed in minutes

  2. Time from application of radio-frequency energy to acute success [ Time Frame: 60 minutes ]
    The target will be where the HIS electrogram amplitude is greatest and where the QRS complex from pacing is narrowest.

  3. Frequency of ablation application between the 2 arms [ Time Frame: 60 minutes ]
    The number of times radio-frequency from the catheter is delivered

  4. Duration of ablation application [ Time Frame: 60 minutes ]
    The amount of time for each radio-frequency application measured in seconds.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of persistent or permanent atrial fibrillation documented on electrocardiography
  2. Patients must meet American College of Cardiology and Heart Rhythm Society "ACC/HRS" guidelines for atrioventricular nodal ablation procedure
  3. Patients must be available for at least 1 month post procedure
  4. Patients must be greater than or equal to 18 years old.

Exclusion Criteria:

1. Patients who do not meet ACC/HRS indications for av nodal ablation


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): NCT03114124


Locations
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United States, Florida
University of Florida
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: John N Catanzaro, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03114124    
Other Study ID Numbers: ir-iis02
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Florida:
ablation
atrioventricular node
microfidelity
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes