Clinical trial NCT03232645: Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation
Official title: ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
timeFrame: Day 0 and 3 months
Secondary outcomes:
measure: Local Impedance and Local Impedance Change and PVI Gaps at Day Zero
timeFrame: Day 0
measure: Number of Gaps at Day Zero
timeFrame: Day 0
measure: Baseline Local Impedance and Local Impedance Change at Day Zero
timeFrame: Day 0
measure: Maximum Number of Gaps Per PV Segment at Day Zero
timeFrame: Day 0
measure: Local Impedance in Segments With Maximum Number of Gaps at Day Zero
timeFrame: Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Karlsruhe
country: Germany
facility: Stadtisches Klinikum Karlsruhe
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Clinica Universitaria de Navarra
name: Ignacio Garcia Bolao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäres Herzzentrum Hamburg
name: Bruno Reissmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stadtisches Klinikum Karlsruhe
name: Armin Luik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Pierre Jais, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Freeman Health System
name: Moloy Das, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Waqas Ullah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Bolao I, Ramos P, Luik A, S Sulkin M, R Gutbrod S, Oesterlein T, I Laughner J, Richards E, Meyer C, Yue A, Ullah W, Shepherd E, Das M. Local Impedance Drop Predicts Durable Conduction Block in Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2022 May;8(5):595-604. doi: 10.1016/j.jacep.2022.01.009. Epub 2022 Feb 23.