To Assess the Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 8
- Locations
- 4
- Primary Endpoint
- Number of patients with Esophageal Injury
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All Patients ≥ 18 years of age
- •Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation.
Exclusion Criteria
- •Patients unable to give consent
- •Who do not have De-novo AF.
Outcomes
Primary Outcomes
Number of patients with Esophageal Injury
Time Frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Esophageal Injury
Number of patients with TIA/CVA
Time Frame: 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
Time Frame: 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
Time Frame: 1 year
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - pulmonary vein stenosis
Esophageal Temp max (existing protocol)
Time Frame: 1 day
Esophageal temp max (existing protocol)
Efficacy rate of loss of unipolar negative component
Time Frame: 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
Time Frame: 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"
Time Frame: 1 day
Esophageal "Time above threshold"
Number of patients with Bleeding/Hematoma
Time Frame: 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
Time Frame: 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"
Time Frame: 1 day
Esophageal "Time to return to baseline"
Images comparing PURE EP unipolar signals against Claris unipolar signals
Time Frame: 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 Outcomes
- Compare 1st pass isolation(1 day)
- 6-month freedom from AF(6 months)
- Location of Catheter tip(1 day)
- Duration of HFA channel compared to Bipolar(1 day)
- Total RF Time(1 day)
- Discrimination with High Frequency Algorithm as a confirmation tool(1 day)
- Redo's within 1 year(1 year)