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A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator (Omny-IRE)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF) defined as as atrial fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant Selected for AF ablation procedure by pulmonary vein isolation (PVI) Willing and capable of providing consent Able and willing to comply with all pre-, post- and follow-up testing and requirements Exclusion Criteria: Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [body mass index greater than {>} 40 kilograms per meter square {kg/m^2}]), renal insufficiency (with an estimated creatinine clearance less than (<) 30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2]) Previous left atrium (LA) ablation or surgery Participants known to require ablation outside the PV region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White) Previously diagnosed with persistent AF (> 7 days in duration) Severe dilatation of the left atrium (LA) (left anterior descending artery [LAD] >50 millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE]) Presence of LA thrombus Severely compromised left ventricular ejection fraction (left ventricular ejection fraction [LVEF] <40 percentage [%]) 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) History of a documented thromboembolic event (including transient ischemic attack [TIA]) within the past 6 months Previous percutaneous coronary intervention (PCI) / myocardial infarction (MI) within the past 2 months Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure Unstable angina pectoris within the past 6 months Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months Significant pulmonary disease (example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms Known significant pulmonary vein (PV) anomaly 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 implanted pacemaker or implantable cardioverter-defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy Presence of a condition that precludes vascular access (such as Inferior Vena Cava [IVC] filter) Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being 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) Known contraindication for magnetic resonance imaging (MRI) such as use of contrast agents due to advanced renal disease, claustrophobia etcetra. (at principle investigator [PI] discretion) Presence of iron-containing metal fragments in the body Known unresolved pre-existing neurological deficit Known uncontrolled significant gastroesophageal reflux disease (GERD)

Sites / Locations

  • O.L.V. ZiekenhuisRecruiting
  • AZ Sint-JanRecruiting
  • Ziekenhuis Oost-Limburg
  • Jessa Ziekenhuis - Campus Virga JesseRecruiting
  • Montreal Heart Institute
  • McGill University Health Centre
  • KBC Split
  • IKEM
  • Nemocnice na Homolce
  • MVZ CCB Frankfurt und Main Taunus GbR
  • Generale Regionale F. Miulli
  • Vilnius University
  • Maastricht UMC+

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator

Arm Description

Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).

Outcomes

Primary Outcome Measures

Number of Participants with Primary Adverse Events (PAE's)
Number of Participants with incidence of PAEs (within 7 days following the ablation procedure) will be reported. PAE's will include the following adverse events atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis, device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.
Percentage of Participants with Acute Effectiveness
Percentage of participants with acute effectiveness will be reported. Acute effectiveness is an electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure. Use of a non-study device to achieve PV isolation is considered an acute procedural failure.

Secondary Outcome Measures

12-month Effectiveness: Number of Participants who Achieved Freedom from Documented Atrial Arrhythmia Episodes During the Effectiveness Evaluation period (AF, AT or AFL of Unknown Origin) within Day 91 to Day 365 Post Index Procedure
12-month effectiveness: Number of participants rate of Freedom from documented (symptomatic and asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of unknown origin) episodes assessed during the effectiveness evaluation period (Day 91 to Day 365 days post index procedure will be reported. Freedom from atrial arrhythmia will be reported based on electrocardiographic data (greater than or equal to [>=30] seconds on arrhythmia monitoring device) during the effectiveness evaluation period on or off antiarrhythmic therapy. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12- month effectiveness failure.

Full Information

First Posted
July 25, 2023
Last Updated
October 10, 2023
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05971693
Brief Title
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
Acronym
Omny-IRE
Official Title
Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Arm Type
Experimental
Arm Description
Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
Intervention Type
Device
Intervention Name(s)
OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Intervention Description
Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping [stimulating and recording] and, when used with a Generator, for cardiac ablation).
Primary Outcome Measure Information:
Title
Number of Participants with Primary Adverse Events (PAE's)
Description
Number of Participants with incidence of PAEs (within 7 days following the ablation procedure) will be reported. PAE's will include the following adverse events atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis, device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.
Time Frame
7 days post-ablation procedure on Day 0 (up to Day 7)
Title
Percentage of Participants with Acute Effectiveness
Description
Percentage of participants with acute effectiveness will be reported. Acute effectiveness is an electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure. Use of a non-study device to achieve PV isolation is considered an acute procedural failure.
Time Frame
Immediate post-procedure
Secondary Outcome Measure Information:
Title
12-month Effectiveness: Number of Participants who Achieved Freedom from Documented Atrial Arrhythmia Episodes During the Effectiveness Evaluation period (AF, AT or AFL of Unknown Origin) within Day 91 to Day 365 Post Index Procedure
Description
12-month effectiveness: Number of participants rate of Freedom from documented (symptomatic and asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of unknown origin) episodes assessed during the effectiveness evaluation period (Day 91 to Day 365 days post index procedure will be reported. Freedom from atrial arrhythmia will be reported based on electrocardiographic data (greater than or equal to [>=30] seconds on arrhythmia monitoring device) during the effectiveness evaluation period on or off antiarrhythmic therapy. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12- month effectiveness failure.
Time Frame
Within Day 91 to Day 365 post-ablation procedure (on Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF) defined as as atrial fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant Selected for AF ablation procedure by pulmonary vein isolation (PVI) Willing and capable of providing consent Able and willing to comply with all pre-, post- and follow-up testing and requirements Exclusion Criteria: Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [body mass index greater than {>} 40 kilograms per meter square {kg/m^2}]), renal insufficiency (with an estimated creatinine clearance less than (<) 30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2]) Previous left atrium (LA) ablation or surgery Participants known to require ablation outside the PV region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White) Previously diagnosed with persistent AF (> 7 days in duration) Severe dilatation of the left atrium (LA) (left anterior descending artery [LAD] >50 millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE]) Presence of LA thrombus Severely compromised left ventricular ejection fraction (left ventricular ejection fraction [LVEF] <40 percentage [%]) 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) History of a documented thromboembolic event (including transient ischemic attack [TIA]) within the past 6 months Previous percutaneous coronary intervention (PCI) / myocardial infarction (MI) within the past 2 months Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure Unstable angina pectoris within the past 6 months Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months Significant pulmonary disease (example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms Known significant pulmonary vein (PV) anomaly 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 implanted pacemaker or implantable cardioverter-defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy Presence of a condition that precludes vascular access (such as Inferior Vena Cava [IVC] filter) Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being 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) Known contraindication for magnetic resonance imaging (MRI) such as use of contrast agents due to advanced renal disease, claustrophobia etcetra. (at principle investigator [PI] discretion) Presence of iron-containing metal fragments in the body Known unresolved pre-existing neurological deficit Known uncontrolled significant gastroesophageal reflux disease (GERD)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
+32 479 97 05 05
Email
nmacours1@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial
Organizational Affiliation
Biosense Webster, Inc., a division of Johnson & Johnson
Official's Role
Study Director
Facility Information:
Facility Name
O.L.V. Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
KBC Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
IKEM
City
Prague
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Nemocnice na Homolce
City
Prague
ZIP/Postal Code
150 30 District 5
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
MVZ CCB Frankfurt und Main Taunus GbR
City
Frankfurt a.M.
ZIP/Postal Code
60431
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Generale Regionale F. Miulli
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Vilnius University
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Maastricht UMC+
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator

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