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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03733392




Registration number
NCT03733392
Ethics application status
Date submitted
30/10/2018
Date registered
7/11/2018
Date last updated
16/04/2024

Titles & IDs
Public title
Advisor HD Grid Observational Study
Scientific title
Advisor High Density (HD) Grid Mapping Catheter Observational Study
Secondary ID [1] 0 0
ABT-CIP-10257
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Atrial Fibrillation 0 0
Ventricular Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Advisor HD Grid Mapping Catheter, Sensor Enabled

Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Subjects With Acute Success
Timepoint [1] 0 0
Immediate post procedure
Primary outcome [2] 0 0
Rate of Subjects With Long-term Success
Timepoint [2] 0 0
PersAF (12 months), VT (6-months)
Secondary outcome [1] 0 0
Overall Procedure Time
Timepoint [1] 0 0
During procedure
Secondary outcome [2] 0 0
Radiofrequency (RF) Time
Timepoint [2] 0 0
During Procedure
Secondary outcome [3] 0 0
Fluoroscopy Time
Timepoint [3] 0 0
During Procedure
Secondary outcome [4] 0 0
Mapping Time Associated With Mapping Arrhythmia
Timepoint [4] 0 0
During Procedure
Secondary outcome [5] 0 0
Number of Mapping Points Collected
Timepoint [5] 0 0
During Procedure
Secondary outcome [6] 0 0
Number of Used Mapping Points Per Minute
Timepoint [6] 0 0
During Procedure
Secondary outcome [7] 0 0
Substrate Characteristics Identified
Timepoint [7] 0 0
During Procedure
Secondary outcome [8] 0 0
Map Type Used to Define Ablation Strategy
Timepoint [8] 0 0
During Procedure
Secondary outcome [9] 0 0
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.
Timepoint [9] 0 0
During Procedure
Secondary outcome [10] 0 0
Maneuverability of HD Grid Catheter
Timepoint [10] 0 0
During Procedure
Secondary outcome [11] 0 0
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms
Timepoint [11] 0 0
During Procedure
Secondary outcome [12] 0 0
Ablation Strategy(s) Used for PersAF Subjects
Timepoint [12] 0 0
During Procedure
Secondary outcome [13] 0 0
Ablation Strategy(s) Used for VT Subjects
Timepoint [13] 0 0
During the Procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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%

-

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2021
Sample size
Target
Accrual to date
Final
379
Recruitment in Australia
Recruitment state(s)
NSW,QslndSA,Victor
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2066 - Melbourne
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
L Austr
Country [2] 0 0
Austria
State/province [2] 0 0
Upper Austria
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Denmark
State/province [6] 0 0
Arhus
Country [7] 0 0
France
State/province [7] 0 0
Alsace
Country [8] 0 0
France
State/province [8] 0 0
Auvergn
Country [9] 0 0
France
State/province [9] 0 0
ILE
Country [10] 0 0
Germany
State/province [10] 0 0
Bavaria
Country [11] 0 0
Germany
State/province [11] 0 0
N. Rhin
Country [12] 0 0
Germany
State/province [12] 0 0
Saxony
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Italy
State/province [14] 0 0
Lombard
Country [15] 0 0
Italy
State/province [15] 0 0
Piedmonte
Country [16] 0 0
Netherlands
State/province [16] 0 0
Zuid
Country [17] 0 0
Portugal
State/province [17] 0 0
Lisbon
Country [18] 0 0
South Africa
State/province [18] 0 0
Cape Town
Country [19] 0 0
Spain
State/province [19] 0 0
Cantabr
Country [20] 0 0
Spain
State/province [20] 0 0
Catalon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03733392
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03733392