LOCALIZEELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study
Ablation procedure
Arrhythmias, Cardiac+3
+ Atrial Fibrillation
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: January 8, 2018
Actual date on which the first participant was enrolled.The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.62 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * • History of recurrent symptomatic PAF with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days. * Refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD); * Eligible for an ablation procedure with the Rhythmia HDx mapping system (software version 2.0 or any future commercially available Software Version), IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter according to current international and local guidelines (and future revisions) and per physician discretion; * Subjects who are willing and capable of providing informed consent; * Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center; * Age 18 to 80 Exclusion Criteria: * • Diagnosed with any of the following heart conditions within 90 days (3 months) prior to enrollment: 1. New York Heart Association (NYHA) Class III or IV 2. Left ventricular ejection fraction (LVEF) \<35% 3. Left atrial (LA) diameter \>5.5 cm 4. Unstable angina or ongoing myocardial ischemia (OMI) 5. Transmural myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery * Active systemic infection or sepsis; * Undergone any left atrial heart ablation procedure, either surgical or catheter ablation * Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route * Subject has a Left Atrial Appendage Closure (LAAC) or Percutaneous Transcatheter Closure of a Patent Foramen Ovale (PFO) * Subject has persistent or long-standing persistent atrial fibrillation (AF) ( \>1 AF episodes lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year) * Life expectancy ≤ 6 months per physician judgment * Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility; * The subject is unable or not willing to complete follow-up visits and examination for the duration of the study; * Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Universitäres Herzzentrum Hamburg
Hamburg, GermanyStadtisches Klinikum Karlsruhe
Karlsruhe, GermanyClinica Universitaria de Navarra
Pamplona, Spain