Advisor HD Grid Observational Study

Completed

Conditions: Persistent Atrial Fibrillation
Ventricular Tachycardia

Registration Number: NCT03733392

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 379

Inclusion Criteria

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

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
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%

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Subjects With Acute Success	Immediate post procedure	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).
Rate of Subjects With Long-term Success	PersAF (12 months), VT (6-months)	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.

Secondary Outcome Measures

Name	Time	Method
Mapping Time Associated With Mapping Arrhythmia	During Procedure	Defined as the total mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)
Number of Mapping Points Collected	During Procedure	Defined as total number of mapping points collected for the creation of each map.
Radiofrequency (RF) Time	During Procedure	Defined as duration of time RF energy is delivered
Overall Procedure Time	During procedure	Overall procedure time is defined as time from initial catheter insertion to final catheter removal.
Fluoroscopy Time	During Procedure	Defined as total time subject is exposed to fluoroscopy
Number of Used Mapping Points Per Minute	During Procedure	Defined as the total number of mapping points used divided by the relative mapping time
Substrate Characteristics Identified	During Procedure	For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate.
Map Type Used to Define Ablation Strategy	During Procedure	Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.	During Procedure	Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.
Maneuverability of HD Grid Catheter	During Procedure	Defined as the ability to maneuver the HD Grid to each specified anatomic location if attempted, the ability to contact cardiac tissue, and the incidence of induced ectopic beats during maneuvering.
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms	During Procedure	Defined as the proportion of electrograms collected with HD Grid that have better quality/less noise than electrograms collected with the ablation catheter at the same cardiac location as assessed by physician survey.
Ablation Strategy(s) Used for PersAF Subjects	During Procedure	Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for PersAF Pulmonary vein isolation (PVI) Right Superior Pulmonary Vein (RSPV) Right Inferior Pulmonary Vein (RIPV) Left Superior Pulmonary Vein (LSPV) Left Inferior Pulmonary Vein (LIPV)
Ablation Strategy(s) Used for VT Subjects	During the Procedure	Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT.

Trial Locations

Locations (25): Ospedale San Raffaele
🇮🇹
Milano, Lombard, Italy
Herzzentrum Leipzig GmbH
🇩🇪
Leipzig, Saxony, Germany
Skejby University Hospital
🇩🇰
Arhus, Denmark
Pole Sante Republique
🇫🇷
Clermont-Ferrand, Auvergn, France
Institute Cardio. Paris-Sud - Institut Jacques Cartier
🇫🇷
Massy, ILE, France
Medizinische Einrichtungen der Universität zu Köln
🇩🇪
Koln, N. Rhin, Germany
Monash Medical Centre
🇦🇺
Clayton, Victori, Australia
A. ö. Krankenhaus der Elisabethinen Linz
🇦🇹
Linz, Upper Austria, Austria
Hospital Universitario Marqués de Valdecilla
🇪🇸
Santander, Cantabr, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸
Barcelona, Catalon, Spain
Santa Maria Hospital
🇵🇹
Lisboa, Lisbon, Portugal
Ospedale Cardinal Massaia Di Asti
🇮🇹
Asti, Piedmonte, Italy
Christiaan Barnard Memorial Hospital
🇿🇦
Cape Town, South Africa
The Alfred Hospital
🇦🇺
Melbourne, New South Wales, Australia
Flinders Private Hospital
🇦🇺
Bedford Park, South Australia, Australia
KH Wiener Neustadt
🇦🇹
Wiener Neustadt, L Austr, Austria
The Prince Charles Hospital
🇦🇺
Chermside, Qslnd, Australia
UKE Hamburg (Universitatsklinik Eppendorf)
🇩🇪
Hamburg, Germany
Clinique Rhena
🇫🇷
Strasbourg, Alsace, France
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪
Dresden, Saxony, Germany
Institut de Cardiologie de Quebec (Hôpital Laval)
🇨🇦
Québec, Quebec, Canada
Haga Ziekenhuis Locatie Leyenburg
🇳🇱
Den Haag, Zuid, Netherlands
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
Klinikum Fürth
🇩🇪
Furth, Bavaria, Germany
Sunnybrook Health Sciences Centre
🇨🇦
Toronto, Ontario, Canada