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

NCT03114124 | Completed Results FDA Device

• 1 other identifier: ir-iis02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

ablation; atrioventricular node; microfidelity

Outcome Measures

Primary Outcomes (1)

• The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block

  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.

  60 seconds

Secondary Outcomes (1)

• Time From Application of Radio-frequency Energy to Acute Success

  up to 3000 seconds

Study Arms (2)

Bipolar Ablation Catheter

ACTIVE COMPARATOR

Subjects will be randomized by random computer programming to receive standard ablation catheter for their procedure.

Device: Standard Ablation Catheter

MIFI Ablation Catheter

EXPERIMENTAL

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

Interventions

MIFI Catheter DEVICE

Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity

MIFI Ablation Catheter

Standard Ablation Catheter DEVICE

Standard of care for patients with certain cardiac arrhythmias.

Bipolar Ablation Catheter

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andrea Goosen
• Organization: UF Health- Jacksonville

andrea.ggosen@jax.ufl.edu

904-244-5617

Study Officials

• John N Catanzaro, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Standard ablation catheter vs MIFI catheter

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 14, 2017
• Study Start: May 23, 2017
• Primary Completion: September 26, 2019
• Study Completion: November 9, 2019
• Last Updated: September 22, 2021
• Results First Posted: September 1, 2021

Record last verified: 2021-08

Locations

US (1)