Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation (LOCALIZE)

Boston Scientific

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Ablation procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03232645

PM007

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Rhythmia HDx and DirectSense technology

Other group

Description:

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.

Treatment:

Device: Ablation procedure