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

NCT06701292 | Withdrawn FDA Device

• 1 other identifier: HSC-MS-24-0150
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Keywords

Ablation; symptomatic paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (13)

• Day and time to first recurrence of any documented atrial arrhythmias

  an average of 91 days after catheter ablation

• Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring

  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

  6 months follow up

• Number of Procedure-related complications

  end of study (6 months after procedure)

• Number of deaths

  end of study (6 months after procedure)

Study Arms (2)

PVS-PVI

EXPERIMENTAL

Device: PVS-PVI targeted ablation

WACA

ACTIVE COMPARATOR

Device: Wide area circumferential ablation (WACA)

Interventions

Wide area circumferential ablation (WACA) DEVICE

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

WACA

PVS-PVI targeted ablation DEVICE

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.

PVS-PVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramesh Hariharan, D, MRCP,FACC, FHRS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 22, 2024
• Study Start: January 15, 2025
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)