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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03114124
Enrollment
30
Registered
2017-04-14
Start date
2017-05-23
Completion date
2019-11-09
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

ablation, atrioventricular node, microfidelity

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.

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

Interventions

DEVICEMIFI Catheter

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

DEVICEStandard Ablation Catheter

Standard of care for patients with certain cardiac arrhythmias.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.

Intervention model description

Standard ablation catheter vs MIFI catheter

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block60 secondsIdentified 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.

Secondary

MeasureTime frameDescription
Time From Application of Radio-frequency Energy to Acute Successup to 3000 secondsThe target will be where the HIS electrogram amplitude is greatest and where the QRS complex from pacing is narrowest.

Countries

United States

Participant flow

Pre-assignment details

There was no wash out or run-in event. The significant portion of the research was the AV nodal ablation

Participants by arm

ArmCount
Bipolar Ablation Catheter
Subjects will be randomized by random computer programming to receive standard ablation catheter for their procedure. Standard Ablation Catheter: Standard of care for patients with certain cardiac arrhythmias.
15
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 MIFI Catheter: Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity
15
Total30

Baseline characteristics

CharacteristicMIFI Ablation CatheterTotalBipolar Ablation Catheter
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
13 Participants26 Participants13 Participants
Age, Categorical
Between 18 and 65 years
2 Participants4 Participants2 Participants
Age, Continuous72.46 years
STANDARD_DEVIATION 10.4
74.13 years
STANDARD_DEVIATION 10.73
75.8 years
STANDARD_DEVIATION 11.09
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
15 Participants30 Participants15 Participants
Sex: Female, Male
Female
4 Participants10 Participants6 Participants
Sex: Female, Male
Male
11 Participants20 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 15
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

Primary

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.

Time frame: 60 seconds

Population: Randomized

ArmMeasureValue (MEDIAN)
Bipolar Ablation CatheterThe Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block5 seconds
MIFI Ablation CatheterThe Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block4 seconds
Secondary

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.

Time frame: up to 3000 seconds

Population: Randomized

ArmMeasureValue (MEDIAN)
Bipolar Ablation CatheterTime From Application of Radio-frequency Energy to Acute Success615 seconds
MIFI Ablation CatheterTime From Application of Radio-frequency Energy to Acute Success525 seconds

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026