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Atrial FibrillationNCT03114124

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

A study testing MIFI Catheter and Standard Ablation Catheter in people with Atrial Fibrillation, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
MIFI Catheter and Standard Ablation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
23 May 2017to 9 Nov 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida

    Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation A Comparative Pilot Study of Time to Success

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.

Read the detailed description

Introduction In some elderly patients with atrial fibrillation (AF), especially in combination with heart failure, a rate control strategy may be preferred. When pharmacological therapy is ineffective or not tolerated, it is reasonable to perform atrioventricular (AV) node ablation with ventricular pacing as a class IIA indication per current guidelines.

Usually, the procedure is simple and straightforward and complete heart block can be achieved without any difficulty. However, this "simple" procedure can sometimes prove to be a most difficult case. The most common reason for failure to achieve complete heart block is the inability to localize the compact AV node using the His signal with standard intracardiac electrograms. As these patients come to the laboratory in AF, the His signal may be obscured by AF waves. In some patients with a deeper intramyocardial location of the His bundle and compact AV node it becomes necessary to produce deeper ablation lesions using an irrigated catheter to achieve block.

In patients with AF, the target of ablation for the "ablate and pace" approach is the compact AV node, located at the apex of the triangle of Koch. Ideally, ablation is performed at the most proximal penetrating part of the His bundle in order to maintain a proximal automatic junctional rhythm and avoid pacemaker dependence.

Para Hisian pacing is most commonly used to reveal the presence of a septal accessory pathway.

The His bundle is a deep insulated structure and it is difficult to capture it at usual energy outputs. Using a high- output pacing (usually 20 mA at 2 msec) it is possible to directly capture the deeply situated His bundle, which is confirmed by a narrower QRS complex on the paced electrograms. Thus, high-output pacing can be utilized to map the His bundle area in difficult situations.

By applying this electrophysiologic principle of differential tissue capture to help identify the location of the compact AV node, which is in close proximity to the His bundle. Ventricular pacing was performed initially at high output to capture both the basal right ventricular myocardium and the His bundle and the output was gradually lowered to lose His bundle capture. The QRS duration is relatively narrow with high output pacing and increases when the pacing output is lowered, representing ventricular myocardial capture alone. Finally, loss of ventricular capture is seen with further reduction of pacing output. This maneuver has been shown to aid in determining the proximity of the ablation catheter to compact AV node as was validated by successful ablation at this site. Parahisian pacing in conjunction with av nodal ablation has recently been described in the literature.

A novel catheter with three mini electrodes within the ablation tip (IntellaTip MiFi, Boston Scientific, Boston, MA) may enhance the available data for such a signal dependent technique. In this catheter, bipolar signals can be recorded between the three 0.8-mm-wide electrodes that are arranged radially 1.3 mm from the end of the catheter alongside the standard distal and proximal bipolar recordings. Animal studies have already demonstrated that the mini electrodes in this novel catheter are more accurate in identifying conducting gaps in linear ablations than conventional electrode recordings.

Study Aims:

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.

Primary and secondary objectives Primary endpoints

  1. Acute success of ablation identified by a junctional rhythm or complete heart block
  2. Time from application of radiofrequency energy to acute success

Secondary endpoints include

  1. Procedure time
  2. Radiation time
  3. Frequency of ablation application
  4. Duration of ablation application
Being tested
MIFI Catheter, Standard Ablation Catheter
Keywords
ablation, atrioventricular node, microfidelity
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIFI CatheterDevice

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

  • Standard Ablation CatheterDevice

    Standard of care for patients with certain cardiac arrhythmias.

Study groups in NCT03114124
Study groupRoleWhat they receive
Bipolar Ablation CatheterActive comparatorSubjects will be randomized by random computer programming to receive standard ablation catheter for their procedure.
Receives: Device: Standard Ablation Catheter
MIFI Ablation CatheterExperimentalSubjects will be randomized by random computer programming to receive an ablation with MIFI technology. MIFI Catheter contains tightly spaced multielectrode pattern
Receives: Device: MIFI Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 60 seconds

Secondary outcomes (1)
  1. Time From Application of Radio-frequency Energy to Acute Success

    The target will be where the HIS electrogram amplitude is greatest and where the QRS complex from pacing is narrowest.

    Measured: up to 3000 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start23 May 2017
  3. Primary completion26 Sep 2019
  4. Study completion9 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Standard ablation catheter vs MIFI catheter
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03114124
Sponsor's protocol ID
ir-iis02
Status last verified
Aug 2021
First submitted
21 Mar 2017
Last updated
22 Sep 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MIFI Catheter and Standard Ablation Catheter in people with Atrial Fibrillation, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block (time frame: 60 seconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.

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