Clinical trial NCT03733392: Advisor HD Grid Observational Study
Official title: Advisor High Density (HD) Grid Mapping Catheter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Atrial Fibrillation
Ventricular Tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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
14. Indication-specific exclusion criteria including:

    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%

    -

Primary outcomes:
measure: Rate of Subjects With Acute Success
timeFrame: Immediate post procedure
measure: Rate of Subjects With Long-term Success
timeFrame: PersAF (12 months), VT (6-months)
Secondary outcomes:
measure: Overall Procedure Time
timeFrame: During procedure
measure: Radiofrequency (RF) Time
timeFrame: During Procedure
measure: Fluoroscopy Time
timeFrame: During Procedure
measure: Mapping Time Associated With Mapping Arrhythmia
timeFrame: During Procedure
measure: Number of Mapping Points Collected
timeFrame: During Procedure
measure: Number of Used Mapping Points Per Minute
timeFrame: During Procedure
measure: Substrate Characteristics Identified
timeFrame: During Procedure
measure: Map Type Used to Define Ablation Strategy
timeFrame: During Procedure
measure: Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.
timeFrame: During Procedure
measure: Maneuverability of HD Grid Catheter
timeFrame: During Procedure
measure: HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms
timeFrame: During Procedure
measure: Ablation Strategy(s) Used for PersAF Subjects
timeFrame: During Procedure
measure: Ablation Strategy(s) Used for VT Subjects
timeFrame: During the Procedure
Other outcomes:
measure: Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted.
timeFrame: 48 hours
measure: Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted .
timeFrame: 48 hours - 30 days
measure: Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up
timeFrame: Through 12 months
measure: Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects
timeFrame: Baseline, 6 months, 12 months
measure: Quality of Life: EQ-5D-5L Visual Analog Scale Scores in VT Subjects
timeFrame: Baseline, 6 months, 12 months
measure: Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects
timeFrame: Baseline, 6 months, and 12 months
measure: Long-term Success in VT Subjects at 12 Months
timeFrame: 12 months
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Qslnd
city: Bedford Park
country: Australia
facility: Flinders Private Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victori
city: Wiener Neustadt
country: Austria
facility: KH Wiener Neustadt
state: L Austr
city: Linz
country: Austria
facility: A. ö. Krankenhaus der Elisabethinen Linz
state: Upper Austria
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Québec
country: Canada
facility: Institut de Cardiologie de Quebec (Hôpital Laval)
state: Quebec
city: Arhus
country: Denmark
facility: Skejby University Hospital
city: Strasbourg
country: France
facility: Clinique Rhena
state: Alsace
city: Clermont-Ferrand
country: France
facility: Pole Sante Republique
state: Auvergn
city: Massy
country: France
facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier
state: ILE
city: Furth
country: Germany
facility: Klinikum Fürth
state: Bavaria
city: Koln
country: Germany
facility: Medizinische Einrichtungen der Universität zu Köln
state: N. Rhin
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
state: Saxony
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Saxony
city: Hamburg
country: Germany
facility: UKE Hamburg (Universitatsklinik Eppendorf)
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombard
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia Di Asti
state: Piedmonte
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis Locatie Leyenburg
state: Zuid
city: Lisboa
country: Portugal
facility: Santa Maria Hospital
state: Lisbon
city: Cape Town
country: South Africa
facility: Christiaan Barnard Memorial Hospital
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabr
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
state: Catalon
Study officials:
References: