Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) with Omnipolar Mapping Technology

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06701292
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-17
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2025-01-15
• Primary Completion: 2025-04-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Symptomatic paroxysmal AF refractory to at least one Class I or Class III antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications
• A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder
• Capability to provide informed consent

Exclusion Criteria

• Persistent or permanent AF
• Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter
• Reversible causes of AF
• Congenital heart disease
• Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
• Pregnancy
• Known presence of intracardiac thrombus
• Systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia
• Broad vortex-like connections and no clear PVMS to be targeted

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of minutes taken from Initial puncture to transseptal access	From time of Initial puncture to time of transseptal access (an average of 10 minutes)
Number of minutes taken from transseptal access to left atrium 3D map completion	From time of transseptal access to time of left atrium 3D map completion (an average of 15 minutes)
Number of minutes taken from left atrium 3D map completion to when all pulmonary veins are isolated	From time of left atrium 3D map completion to time when all pulmonary veins are isolated (an average of 30-60 minutes)
Number of minutes with catheters in the left atrium	from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)
Time from initial puncture till all sheaths removed	From time of initial puncture to time when all sheaths removed (an average of 90 minutes)
Total time of radiofrequency applications in seconds	from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)
Number of radiofrequency applications used	end of procedure (an average of 1.5 hours after baseline)

Secondary Outcome Measures

Name	Time	Method
Day and time to first recurrence of any documented atrial arrhythmias	an average of 91 days after catheter ablation	This will be remotely monitored with the Internal loop recorder (ILR) monthly and in clinic every 3 months until the end of the follow up
Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring	6 months follow up	This will be remotely monitored with the ILR monthly and in clinic every 3 months until the end of the follow up
Number of Procedure-related complications	end of study (6 months after procedure)	Complications include Atrio-esophageal fistula, Stroke or transient ischemic attack (TIA), Pericardial effusion/cardiac tamponade, PV stenosis , Vascular access-related complications , Diaphragmatic paralysis , other severe complications or other non-severe complications 0.37%
Number of deaths	end of study (6 months after procedure)
Total radiation exposure dose	end of procedure (about 1.5 hours after start of procedure)
Number of participants that need a repeat catheter ablation procedure due to documented recurrence of symptomatic atrial arrhythmia	end of procedure till 6 months after procedure
Number of occurrences of any AF (symptomatic or asymptomatic) documented on ECG or ILR	during the first 90 days following catheter ablation.
Number of participants that visit the emergency room	end of procedure till 6 months after procedure
Number of participants that are hospitalized	end of procedure till 6 months after procedure
Number of incidences of stroke	end of procedure till 6 months after procedure
Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment	Baseline, 6 months after procedure	This is a 6 item questionnaire and the first 5 questions are each is scored from 1(no problem)-5(unable to) for a maximum score of 25, higher number indicating worse outcome. The 6th question is score on likert scale from 0(worst health you can imagine)-100(best health you can imagine), higher score indicating worse outcome
Number of participants that show a need for electrical cardioversion	end of procedure till 6 months after procedure

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States