Completed

LOCALIZEELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ablation procedure

Device
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2018
See protocol details

Summary

Principal SponsorBoston Scientific Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study
Principal SponsorBoston Scientific Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.

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

Suspended

CHU de Bordeaux

Bordeaux, FranceOpen CHU de Bordeaux in Google Maps
Suspended

Universitäres Herzzentrum Hamburg

Hamburg, Germany
Suspended

Stadtisches Klinikum Karlsruhe

Karlsruhe, Germany
Suspended

Clinica Universitaria de Navarra

Pamplona, Spain
Completed6 Study Centers