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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06455098




Registration number
NCT06455098
Ethics application status
Date submitted
7/06/2024
Date registered
12/06/2024
Date last updated
14/08/2024

Titles & IDs
Public title
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Scientific title
Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
Secondary ID [1] 0 0
BWI202303
Universal Trial Number (UTN)
Trial acronym
OMNY-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OMNYPULSE™ Catheter with the TRUPULSE Generator

Experimental: Pulsed Field (PF) Ablation System - Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.


Treatment: Devices: OMNYPULSE™ Catheter with the TRUPULSE Generator
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Primary Adverse Events (PAEs)
Timepoint [1] 0 0
7 days post-procedure
Primary outcome [2] 0 0
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes
Timepoint [2] 0 0
Day 91 to Day 365 post-procedure
Secondary outcome [1] 0 0
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Timepoint [1] 0 0
Baseline, Month 12

Eligibility
Key inclusion criteria
* Diagnosed with symptomatic paroxysmal AF with:

1. At least two symptomatic AF episodes within last six months from enrollment
2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment
* Failed at least one Class I or Class III antiarrhythmic drug
* Willing and capable to provide consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previous surgical or catheter ablation for AF
* Patients known to require ablation outside the PV ostia and outside the CTI region.
* Documented severe dilatation of the left atrium (LAD>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
* Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
* Documented severely compromised left ventricular ejection fraction (LVEF <40%) by imaging within 6 months prior to enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
* Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction [MI] within the past 2 months
* Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
* Valvular cardiac surgical/percutaneous procedure
* Unstable angina within 6 months
* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
* Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Prior diagnosis of pulmonary vein stenosis
* Pre-existing hemi diaphragmatic paralysis
* Acute illness, active systemic infection, or sepsis
* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
* Severe mitral regurgitation
* Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
* Presence of a condition that precludes vascular access
* Current enrollment in an investigational study evaluating another device or drug
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Canberra Heart Rhythm - Garran
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2605 - Garran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biosense Webster, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.
Trial website
https://clinicaltrials.gov/study/NCT06455098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Biosense Webster, Inc. Clinical Trial
Address 0 0
Biosense Webster, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
949-789-3919
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06455098