Advisor HD Grid Observational Study

NCT03733392 | Completed Results

• 1 other identifier: ABT-CIP-10257
• Study Type: observational
• Target: 379
• Locations: 10 countries
• Sites: 23

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

Outcome Measures

Primary Outcomes (2)

• Rate of Subjects With Acute Success

  The rate of acute success is defined as the percent of subjects who received HD Grid mapping and RF energy delivery according to label resulting in acute termination of clinical arrhythmia, defined by termination to sinus rhythm (SR) (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt).

  Immediate post procedure

• Rate of Subjects With Long-term Success

  For PersAF, the rate of long-term success rate is defined as the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) and a new or increased dose in class I/III antiarrhythmic drug (AAD). For VT, the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from recurrence of sustained monomorphic VT and a new or increase dose in class I/III AAD at 6-month follow-up. The percent of subjects who are free from the pre-defined endpoints on or off class I/III AADs is also reported.

  PersAF (12 months), VT (6-months)

Secondary Outcomes (13)

• Overall Procedure Time

  During procedure

• Radiofrequency (RF) Time

  During Procedure

• Fluoroscopy Time

  During Procedure

• Mapping Time Associated With Mapping Arrhythmia

  During Procedure

• Number of Mapping Points Collected

  During Procedure

Other Outcomes (7)

• Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted.

  48 hours

• Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted .

  48 hours - 30 days

• Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up

  Through 12 months

Interventions

Advisor HD Grid Mapping Catheter, Sensor Enabled DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical study will enroll male and female subjects over the age of 18 years who are indicated for cardiac RF ablation with electroanatomical mapping for the treatment of PersAF or substrate-based VT. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any study-specific procedures not considered standard of care.

You may qualify if:

• \. 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

You may not qualify if:

• Life expectancy less than 12 months
• Women who are pregnant or nursing
• Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure
• Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure
• Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure
• Documented cerebro-embolic event within the past 12 months (365 days)
• History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
• Current acute illness or active systemic infection or sepsis
• Currently enrolled in another clinical study that could confound the results of this study
• Any cause for contraindication to ablation procedure or systemic anticoagulation
• 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.
• 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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (25)

The Alfred Hospital

Melbourne, New South Wales, 2066, Australia

Location

The Prince Charles Hospital

Chermside, Qslnd, 4032, Australia

Location

Flinders Private Hospital

Bedford Park, South Australia, 5042, Australia

Location

Monash Medical Centre

Clayton, Victori, 3168, Australia

Location

KH Wiener Neustadt

Wiener Neustadt, L Austr, 2700, Austria

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, Upper Austria, 4020, Austria

Location

St. Paul's Hospital

Vancouver, British Columbia, V6E1M7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, Quebec, G1V 4G5, Canada

Location

Skejby University Hospital

Aarhus, 8200, Denmark

Location

Clinique Rhena

Strasbourg, Alsace, 67200, France

Location

Pole Sante Republique

Clermont-Ferrand, Auvergn, 63050, France

Location

Institute Cardio. Paris-Sud - Institut Jacques Cartier

Massy, ILE, 91300, France

Location

Klinikum Fürth

Fürth, Bavaria, Germany

Location

Medizinische Einrichtungen der Universität zu Köln

Cologne, N. RHIN, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Saxony, 1397, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 4289, Germany

Location

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, 20246, Germany

Location

Ospedale San Raffaele

Milan, Lombard, 20132, Italy

Location

Ospedale Cardinal Massaia Di Asti

Asti, Piedmonte, 1411, Italy

Location

Haga Ziekenhuis Locatie Leyenburg

The Hague, ZUID, 2545AA, Netherlands

Location

Santa Maria Hospital

Lisbon, Lisbon District, 1070-313, Portugal

Location

Christiaan Barnard Memorial Hospital

Cape Town, 8001, South Africa

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabr, 8036, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalon, 8036, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Limitations and Caveats

Due to the coronavirus disease of 2019 (COVID-19) pandemic, early enrollment closures were implemented, thus impacting the study sample size and preventing many PersAF patients from completing Holter monitoring at their 12-month follow-up visit. Additionally, there were VT subjects excluded from non-safety analysis due to off-label use of an ablation catheter. The generalizability of the effectiveness and utility of Advisor HD Grid mapping in VT is limited by the small sample size of subjects.

Results Point of Contact

• Title: Emily Jesser, Ph.D.
• Organization: Abbott

emily.jesser@abbott.com

763-954-1350

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 7, 2018
• Study Start: January 11, 2019
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); DE (5); NL (1); IT (2); FR (3); DK (1); PT (1); ZA (1); CA (3); ES (2)