Clinical trial NCT06701292: Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) with Omnipolar Mapping Technology
Official title: Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves with Omnipolar Mapping Technology - a Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Ablation
symptomatic paroxysmal Atrial Fibrillation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of minutes taken from Initial puncture to transseptal access
timeFrame: From time of Initial puncture to time of transseptal access (an average of 10 minutes)
measure: Number of minutes taken from transseptal access to left atrium 3D map completion
timeFrame: From time of transseptal access to time of left atrium 3D map completion (an average of 15 minutes)
measure: Number of minutes taken from left atrium 3D map completion to when all pulmonary veins are isolated
timeFrame: From time of left atrium 3D map completion to time when all pulmonary veins are isolated (an average of 30-60 minutes)
measure: Number of minutes with catheters in the left atrium
timeFrame: from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)
measure: Time from initial puncture till all sheaths removed
timeFrame: From time of initial puncture to time when all sheaths removed (an average of 90 minutes)
measure: Total time of radiofrequency applications in seconds
timeFrame: from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)
measure: Number of radiofrequency applications used
timeFrame: end of procedure (an average of 1.5 hours after baseline)
Secondary outcomes:
measure: Day and time to first recurrence of any documented atrial arrhythmias
timeFrame: an average of 91 days after catheter ablation
measure: Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring
timeFrame: 3 months follow up
measure: Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring
timeFrame: 6 months follow up
measure: Number of Procedure-related complications
timeFrame: end of study (6 months after procedure)
measure: Number of deaths
timeFrame: end of study (6 months after procedure)
measure: Total radiation exposure dose
timeFrame: end of procedure (about 1.5 hours after start of procedure)
measure: Number of participants that need a repeat catheter ablation procedure due to documented recurrence of symptomatic atrial arrhythmia
timeFrame: end of procedure till 6 months after procedure
measure: Number of occurrences of any AF (symptomatic or asymptomatic) documented on ECG or ILR
timeFrame: during the first 90 days following catheter ablation.
measure: Number of participants that visit the emergency room
timeFrame: end of procedure till 6 months after procedure
measure: Number of participants that are hospitalized
timeFrame: end of procedure till 6 months after procedure
measure: Number of incidences of stroke
timeFrame: end of procedure till 6 months after procedure
measure: Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment
timeFrame: Baseline, 6 months after procedure
measure: Number of participants that show a need for electrical cardioversion
timeFrame: end of procedure till 6 months after procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ramesh Hariharan, D, MRCP,FACC, FHRS
role: PRINCIPAL_INVESTIGATOR
References: