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

NCT ID: NCT03232645

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2020-08-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rhythmia HDx and DirectSense technology

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.

Group Type: OTHER

Ablation procedure

Intervention Type: DEVICE

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

Interventions

Ablation procedure

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ignacio Garcia Bolao, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universitaria de Navarra

Bruno Reissmann, MD

Role: PRINCIPAL_INVESTIGATOR

Universitäres Herzzentrum Hamburg

Armin Luik, MD

Role: PRINCIPAL_INVESTIGATOR

Stadtisches Klinikum Karlsruhe

Pierre Jais, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Moloy Das, MD

Role: PRINCIPAL_INVESTIGATOR

Freeman Health System

Waqas Ullah, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

CHU de Bordeaux

Bordeaux, , France

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Stadtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Clinica Universitaria de Navarra

Pamplona, , Spain

Freeman Hospital

Newcastle, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Countries

France; Germany; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35589172 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PM007

Identifier Type: -

Identifier Source: org_study_id