Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
- Conditions
- Atrial Fibrillation
- Interventions
- Other: Unipolar Polarity Switch LeftOther: Unipolar Polarity Switch Right
- Registration Number
- NCT05464537
- Lead Sponsor
- Kansas City Heart Rhythm Research Foundation
- Brief Summary
The technique of intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.
- Detailed Description
One initial study reported that unipolar atrial EGM modification was a useful end point for RF energy delivery. They compared 2 groups of patients with paroxysmal AF undergoing PVI facilitated by an electroanatomic mapping system, merged preprocedural LA computed tomographic scan, and a circular mapping catheter.
They were the first to use intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI. The technique, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.
As there is scant data is this area with lack of randomized human trials, planned on building and further validating evidence from Bortone et al in demonstrating that loss of unipolar negative component during PVI can serve a great adjuvant tool for achieving durability of PVI with overall lesser procedural time and no significant increase in adverse events.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- All Patients ≥ 18 years of age
- Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation.
- Patients unable to give consent
- Who do not have De-novo AF.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unipolar Polarity Switch Left and CAI-OPR-LAAP Right Unipolar Polarity Switch Left - CAI-OPR-LAAP Left and Unipolar Polarity Switch Right Unipolar Polarity Switch Right -
- Primary Outcome Measures
Name Time Method Number of patients with Esophageal Injury 1 year Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Esophageal Injury
Number of patients with TIA/CVA 1 year Number of patients with intraprocedural and post procedure adverse events and serious adverse events - transient ischemic attack/Cerebrovascular accident (TIA/CVA)
Number of patients with Pericardial Effusion 1 year Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Pericardial Effusion
Number of patients with pulmonary vein stenosis 1 year Number of patients with intraprocedural and post procedure adverse events and serious adverse events - pulmonary vein stenosis
Esophageal Temp max (existing protocol) 1 day Esophageal temp max (existing protocol)
Efficacy rate of loss of unipolar negative component Procedure day and 12 month follow-up day Observe the efficacy rate of loss of unipolar negative component in isolation of the Pulmonary Veins. Loss of unipolar negative component will be assessed during the Radiofrequency ablation procedure. The durability of Pulmonary vein isolation will be assessed at 12 month follow up, if there is recurrence of Atrial fibrillation.
Number of patients with need for open heart surgery 1 year Number of patients with intraprocedural and post procedure adverse events and serious adverse events - need for open heart surgery
Esophageal "Time above threshold" 1 day Esophageal "Time above threshold"
Number of patients with Bleeding/Hematoma 1 year Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Bleeding/Hematoma
Number of patients with phrenic nerve injury 1 year Number of patients with intraprocedural and post procedure adverse events and serious adverse events - phrenic nerve injury
Esophageal "Time to return to baseline" 1 day Esophageal "Time to return to baseline"
Images comparing PURE EP unipolar signals against Claris unipolar signals 1 day Observe if the quality of PURE EP's unipolar signals are acutely and better suited for lesion assessment? This outcome compares mapping images with site of activation to the PURE EP electrogram and compare if they correspond to each other.
- Secondary Outcome Measures
Name Time Method Compare 1st pass isolation 1 day Compare 1st pass isolation in the Unipolar polarity switch group to Carto's Ablation Index per Overland Park Regional's Left Atrial Ablation Protocol (CAI-OPR-LAAP)
6-month freedom from AF 6 months 6-month freedom from AF
Location of Catheter tip 1 day Location of Catheter tip (LSPV, RSPV, RIPV, LIPV, LAA, Other) (carto image)
Duration of HFA channel compared to Bipolar 1 day Duration of HFA channel compared to Bipolar, Was there both a near and far field component?
Total RF Time 1 day Total RF Time in pulmonary veins with Unipolar polarity switch as endpoint vs. CAI-OPR-LAAP
Discrimination with High Frequency Algorithm as a confirmation tool 1 day In Left Superior Vein, Right Superior Vein, and Right Inferior Vein, validate Near Field and Far Field Discrimination with High Frequency Algorithm as a confirmation tool (Visitag #'s annotated into PURE EP)
Redo's within 1 year 1 year Redo's within 1 year which vein randomized group reconnected
Trial Locations
- Locations (2)
Kansas City Heart Rhythm Institute
🇺🇸Overland Park, Kansas, United States
Overland Park Regional Medical Center
🇺🇸Overland Park, Kansas, United States