N/A
Completed N=30
Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation
Source: ClinicalTrials.gov NCT03114124 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block — 5; 4 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Time Differences Between the 2 Arms for Acute Success of Ablation Identified by a Junctional Rhythm or Complete Heart Block |
5; 4 | — |
| SECONDARY Time From Application of Radio-frequency Energy to Acute Success |
615; 525 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Patients who do not meet ACC/HRS indications for av nodal ablation
Data sourced from ClinicalTrials.gov (NCT03114124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.