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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation procedure
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • CHU de Bordeaux
  • Universitäres Herzzentrum Hamburg
  • Stadtisches Klinikum Karlsruhe
  • Clinica Universitaria de Navarra
  • Freeman Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rhythmia HDx and DirectSense technology

Arm 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.

Outcomes

Primary Outcome Measures

Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure. *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.

Secondary Outcome Measures

Local Impedance and Local Impedance Change and PVI Gaps at Day Zero
Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0). *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
Number of Gaps at Day Zero
At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.
Baseline Local Impedance and Local Impedance Change at Day Zero
Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.
Maximum Number of Gaps Per PV Segment at Day Zero
At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.
Local Impedance in Segments With Maximum Number of Gaps at Day Zero
Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps

Full Information

First Posted
July 20, 2017
Last Updated
August 11, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03232645
Brief Title
Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation
Acronym
LOCALIZE
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal 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
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhythmia HDx and DirectSense technology
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Ablation procedure
Intervention Description
Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter
Primary Outcome Measure Information:
Title
Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
Description
Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure. *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
Time Frame
Day 0 and 3 months
Secondary Outcome Measure Information:
Title
Local Impedance and Local Impedance Change and PVI Gaps at Day Zero
Description
Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0). *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
Time Frame
Day 0
Title
Number of Gaps at Day Zero
Description
At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.
Time Frame
Day 0
Title
Baseline Local Impedance and Local Impedance Change at Day Zero
Description
Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.
Time Frame
Day 0
Title
Maximum Number of Gaps Per PV Segment at Day Zero
Description
At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.
Time Frame
Day 0
Title
Local Impedance in Segments With Maximum Number of Gaps at Day Zero
Description
Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: New York Heart Association (NYHA) Class III or IV Left ventricular ejection fraction (LVEF) <35% Left atrial (LA) diameter >5.5 cm Unstable angina or ongoing myocardial ischemia (OMI) 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Garcia Bolao, MD
Organizational Affiliation
Clinica Universitaria de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Reissmann, MD
Organizational Affiliation
Universitäres Herzzentrum Hamburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Armin Luik, MD
Organizational Affiliation
Stadtisches Klinikum Karlsruhe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Jais, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moloy Das, MD
Organizational Affiliation
Freeman Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waqas Ullah, MD
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
Country
Germany
Facility Name
Stadtisches Klinikum Karlsruhe
City
Karlsruhe
Country
Germany
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
Citations:
PubMed Identifier
35589172
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.
Results Reference
derived

Learn more about this trial

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

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