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

NCT03232645 | Completed Results

• 1 other identifier: PM007
• Study Type: interventional
• Target: 62
• Locations: 4 countries
• Sites: 6

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 and 3 months

Secondary Outcomes (5)

• Local Impedance and Local Impedance Change and PVI Gaps at Day Zero

  Day 0

• Number of Gaps at Day Zero

  Day 0

• Baseline Local Impedance and Local Impedance Change at Day Zero

  Day 0

• Maximum Number of Gaps Per PV Segment at Day Zero

  Day 0

• Local Impedance in Segments With Maximum Number of Gaps at Day Zero

  Day 0

Study Arms (1)

Rhythmia HDx and DirectSense technology

OTHER

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.

Device: Ablation procedure

Interventions

Ablation procedure DEVICE

Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter

Rhythmia HDx and DirectSense technology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (6)

CHU de Bordeaux

Bordeaux, France

Location

Universitäres Herzzentrum Hamburg

Hamburg, Germany

Location

Stadtisches Klinikum Karlsruhe

Karlsruhe, Germany

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35589172 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Boston Scientific

alberto.belligoli@bsci.com

00393421994999

Study Officials

• Ignacio Garcia Bolao, MD

  Clinica Universitaria de Navarra

  PRINCIPAL INVESTIGATOR

• Bruno Reissmann, MD

  Universitäres Herzzentrum Hamburg

  PRINCIPAL INVESTIGATOR

• Armin Luik, MD

  Stadtisches Klinikum Karlsruhe

  PRINCIPAL INVESTIGATOR

• Pierre Jais, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Moloy Das, MD

  Freeman Health System

  PRINCIPAL INVESTIGATOR

• Waqas Ullah, MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 28, 2017
• Study Start: January 8, 2018
• Primary Completion: June 23, 2020
• Study Completion: August 5, 2020
• Last Updated: September 5, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ES (1); DE (2); GB (2)