Trial Outcomes & Findings for Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation (NCT NCT03114124)

NCT ID: NCT03114124

Last Updated: 2021-09-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 60 seconds
• Results posted on: 2021-09-22

Participant Flow

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

Participant milestones

Measure	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.	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
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Bipolar Ablation Catheter n=15 Participants 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.	MIFI Ablation Catheter n=15 Participants 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	Total n=30 Participants Total of all reporting groups
Sex: Female, Male Male	9 Participants n=15 Participants	11 Participants n=15 Participants	20 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=15 Participants	2 Participants n=15 Participants	4 Participants n=30 Participants
Age, Categorical >=65 years	13 Participants n=15 Participants	13 Participants n=15 Participants	26 Participants n=30 Participants
Age, Continuous	75.8 years STANDARD_DEVIATION 11.09 • n=15 Participants	72.46 years STANDARD_DEVIATION 10.4 • n=15 Participants	74.13 years STANDARD_DEVIATION 10.73 • n=30 Participants
Sex: Female, Male Female	6 Participants n=15 Participants	4 Participants n=15 Participants	10 Participants n=30 Participants

PRIMARY outcome

Timeframe: 60 seconds

Population: Randomized

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.

Outcome measures

Measure	Bipolar Ablation Catheter n=15 Participants 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.	MIFI Ablation Catheter n=15 Participants 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
The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block	5 seconds Interval 3.0 to 16.0	4 seconds Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: up to 3000 seconds

Population: Randomized

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

Outcome measures

Measure	Bipolar Ablation Catheter n=15 Participants 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.	MIFI Ablation Catheter n=15 Participants 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
Time From Application of Radio-frequency Energy to Acute Success	615 seconds Interval 277.0 to 2778.0	525 seconds Interval 110.0 to 1371.0

Adverse Events

Bipolar Ablation Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MIFI Ablation Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrea Goosen

UF Health- Jacksonville

Phone: 904-244-5617

Email: andrea.ggosen@jax.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place