Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
Scientific title
Advisor High Density (HD) Grid Mapping Catheter Observational Study
Query!
Secondary ID [1]
0
0
ABT-CIP-10257
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Persistent Atrial Fibrillation
0
0
Query!
Ventricular Tachycardia
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Rate of Subjects With Acute Success
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Immediate post procedure
Query!
Primary outcome [2]
0
0
Rate of Subjects With Long-term Success
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
PersAF (12 months), VT (6-months)
Query!
Secondary outcome [1]
0
0
Overall Procedure Time
Query!
Assessment method [1]
0
0
Overall procedure time is defined as time from initial catheter insertion to final catheter removal.
Query!
Timepoint [1]
0
0
During procedure
Query!
Secondary outcome [2]
0
0
Radiofrequency (RF) Time
Query!
Assessment method [2]
0
0
Defined as duration of time RF energy is delivered
Query!
Timepoint [2]
0
0
During Procedure
Query!
Secondary outcome [3]
0
0
Fluoroscopy Time
Query!
Assessment method [3]
0
0
Defined as total time subject is exposed to fluoroscopy
Query!
Timepoint [3]
0
0
During Procedure
Query!
Secondary outcome [4]
0
0
Mapping Time Associated With Mapping Arrhythmia
Query!
Assessment method [4]
0
0
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)
Query!
Timepoint [4]
0
0
During Procedure
Query!
Secondary outcome [5]
0
0
Number of Mapping Points Collected
Query!
Assessment method [5]
0
0
Defined as total number of mapping points collected for the creation of each map.
Query!
Timepoint [5]
0
0
During Procedure
Query!
Secondary outcome [6]
0
0
Number of Used Mapping Points Per Minute
Query!
Assessment method [6]
0
0
Defined as the total number of mapping points used divided by the relative mapping time
Query!
Timepoint [6]
0
0
During Procedure
Query!
Secondary outcome [7]
0
0
Substrate Characteristics Identified
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
During Procedure
Query!
Secondary outcome [8]
0
0
Map Type Used to Define Ablation Strategy
Query!
Assessment method [8]
0
0
Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.
Query!
Timepoint [8]
0
0
During Procedure
Query!
Secondary outcome [9]
0
0
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.
Query!
Assessment method [9]
0
0
Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.
Query!
Timepoint [9]
0
0
During Procedure
Query!
Secondary outcome [10]
0
0
Maneuverability of HD Grid Catheter
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
During Procedure
Query!
Secondary outcome [11]
0
0
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
During Procedure
Query!
Secondary outcome [12]
0
0
Ablation Strategy(s) Used for PersAF Subjects
Query!
Assessment method [12]
0
0
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)
Query!
Timepoint [12]
0
0
During Procedure
Query!
Secondary outcome [13]
0
0
Ablation Strategy(s) Used for VT Subjects
Query!
Assessment method [13]
0
0
Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT.
Query!
Timepoint [13]
0
0
During the Procedure
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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%
-
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/01/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
27/05/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
379
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QslndSA,Victor
Query!
Recruitment hospital [1]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [2]
0
0
The Prince Charles Hospital - Chermside
Query!
Recruitment hospital [3]
0
0
Flinders Private Hospital - Bedford Park
Query!
Recruitment hospital [4]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment postcode(s) [1]
0
0
2066 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [3]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [4]
0
0
3168 - Clayton
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
L Austr
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Upper Austria
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
British Columbia
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
Ontario
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Quebec
Query!
Country [6]
0
0
Denmark
Query!
State/province [6]
0
0
Arhus
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Alsace
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Auvergn
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
ILE
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Bavaria
Query!
Country [11]
0
0
Germany
Query!
State/province [11]
0
0
N. Rhin
Query!
Country [12]
0
0
Germany
Query!
State/province [12]
0
0
Saxony
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Hamburg
Query!
Country [14]
0
0
Italy
Query!
State/province [14]
0
0
Lombard
Query!
Country [15]
0
0
Italy
Query!
State/province [15]
0
0
Piedmonte
Query!
Country [16]
0
0
Netherlands
Query!
State/province [16]
0
0
Zuid
Query!
Country [17]
0
0
Portugal
Query!
State/province [17]
0
0
Lisbon
Query!
Country [18]
0
0
South Africa
Query!
State/province [18]
0
0
Cape Town
Query!
Country [19]
0
0
Spain
Query!
State/province [19]
0
0
Cantabr
Query!
Country [20]
0
0
Spain
Query!
State/province [20]
0
0
Catalon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Abbott Medical Devices
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03733392
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03733392
Download to PDF