Advisor HD Grid Observational Study

NCT ID: NCT03733392

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 379 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2021-05-27

Brief Summary

The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called "HD Grid") and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called "EnSite Precision") with HD Wave Solution™ voltage mapping (hereafter called "HD Wave Solution") in subjects with persistent atrial fibrillation (PersAF) or ventricular tachycardia (VT) in real-world clinical settings.

Conditions

Persistent Atrial Fibrillation; Ventricular Tachycardia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Advisor HD Grid Mapping Catheter, Sensor Enabled

The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule 2. Over 18 years of age 3. Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT 4. Subject is diagnosed with either PersAF OR VT as defined by:

a. Persistent AF: i. Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months b. VT: i. Sustained monomorphic ventricular tachycardia with record of VT event within last 6 months and history of prior myocardial infarction

Exclusion Criteria

1. Life expectancy less than 12 months

2. Women who are pregnant or nursing

3. Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure

4. Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure

5. Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure

6. Documented cerebro-embolic event within the past 12 months (365 days)

7. History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months

8. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)

9. Current acute illness or active systemic infection or sepsis

10. Currently enrolled in another clinical study that could confound the results of this study

11. Any cause for contraindication to ablation procedure or systemic anticoagulation

12. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results.

13. Vulnerable patient or individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of autonomy

a. PersAF: i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause.

ii. Left atrial diameter (LAD) > 55 mm (parasternal long axis view) iii. Left ventricular ejection fraction (LVEF) < 40% iv. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV v. Presence of implanted implantable cardioverter-defibrillator (ICD)/implantable cardiac resynchronization therapy defibrillator (CRT-D).

b. VT: i. VT/Ventricular Fibrillation (VF) thought to be from channelopathies ii. Active ischemia or other reversible cause of VT iii. Incessant VT at time of procedure iv. Implanted with a ventricular assist device (VAD) (e.g. TandemHeart) v. Chronic NYHA Class IV heart failure vi. Ejection fraction < 15%

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

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Alfred Hospital

Melbourne, New South Wales, Australia

The Prince Charles Hospital

Chermside, Qslnd, Australia

Flinders Private Hospital

Bedford Park, South Australia, Australia

Monash Medical Centre

Clayton, Victori, Australia

KH Wiener Neustadt

Wiener Neustadt, L Austr, Austria

A. ö. Krankenhaus der Elisabethinen Linz

Linz, Upper Austria, Austria

St. Paul's Hospital

Vancouver, British Columbia, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, Quebec, Canada

Skejby University Hospital

Aarhus, , Denmark

Clinique Rhena

Strasbourg, Alsace, France

Pole Sante Republique

Clermont-Ferrand, Auvergn, France

Institute Cardio. Paris-Sud - Institut Jacques Cartier

Massy, ILE, France

Klinikum Fürth

Fürth, Bavaria, Germany

Medizinische Einrichtungen der Universität zu Köln

Cologne, N. RHIN, Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Saxony, Germany

Herzzentrum Leipzig GmbH

Leipzig, Saxony, Germany

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, , Germany

Ospedale San Raffaele

Milan, Lombard, Italy

Ospedale Cardinal Massaia Di Asti

Asti, Piedmonte, Italy

Haga Ziekenhuis Locatie Leyenburg

The Hague, ZUID, Netherlands

Santa Maria Hospital

Lisbon, Lisbon District, Portugal

Christiaan Barnard Memorial Hospital

Cape Town, , South Africa

Hospital Universitario Marqués de Valdecilla

Santander, Cantabr, Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalon, Spain

Countries

Australia; Austria; Canada; Denmark; France; Germany; Italy; Netherlands; Portugal; South Africa; Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10257

Identifier Type: -

Identifier Source: org_study_id