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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Omnipolar technology will be used to analyze all PVs and delineate the PVMS. Once identified, PVMS will be marked and described in a clockface fashion using a lateral view of the vein.Ablation will target the PVMS using the same power and force parameters as described for the WACA procedure. Effective ablation lesions and distance between ablation spots will be represented in the same manner too. Lesions should cover at least 5 mm outside the PVMS delineation on both PVMS borders of each myocardial sleeve. PVI will be demonstrated with the same technique described in the WACA procedure. The PVI will be verified for each vein 10 minutes after the initial achievement of PVI.
After generating the 3D electroanatomical map of the heart to understand where treatment needs to be applied,using a tool called radiofrequency (RF) ablation, small burns will be made around the veins to block abnormal electrical signals. Each burn is applied with up to 50 watts of power and lasts up to 10 seconds.The ablation tool will press down with a force of around 10-20 grams.The mapping system (NAVX software) shows the burns on the 3D map
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of minutes taken from Initial puncture to transseptal access
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)
Time from initial puncture till all sheaths removed
Time frame: From time of initial puncture to time when all sheaths removed (an average of 90 minutes)
Total time of radiofrequency applications in seconds
Time frame: from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)
Number of radiofrequency applications used
Time frame: end of procedure (an average of 1.5 hours after baseline)
Day and time to first recurrence of any documented atrial arrhythmias
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 frame: an average of 91 days after catheter ablation
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Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring
This will be remotely monitored with the ILR monthly and in clinic every 3 months until the end of the follow up
Time frame: 3 months 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
This will be remotely monitored with the ILR monthly and in clinic every 3 months until the end of the follow up
Time frame: 6 months follow up
Number of Procedure-related complications
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%
Time frame: end of study (6 months after procedure)
Number of deaths
Time frame: end of study (6 months after procedure)
Total radiation exposure dose
Time frame: 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
Time frame: end of procedure till 6 months after procedure
Number of occurrences of any AF (symptomatic or asymptomatic) documented on ECG or ILR
Time frame: during the first 90 days following catheter ablation.
Number of participants that visit the emergency room
Time frame: end of procedure till 6 months after procedure
Number of participants that are hospitalized
Time frame: end of procedure till 6 months after procedure
Number of incidences of stroke
Time frame: end of procedure till 6 months after procedure
Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment
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
Time frame: Baseline, 6 months after procedure
Number of participants that show a need for electrical cardioversion
Time frame: end of procedure till 6 months after procedure