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Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology

NCT06701292 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-01-28

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

PVS-PVI targeted ablation

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.

DEVICE

Wide area circumferential ablation (WACA)

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Ramesh Hariharan, D, MRCP,FACC, FHRS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-04-30
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06701292 on ClinicalTrials.gov