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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
Titles & IDs
Public title
Advisor HD Grid Observational Study
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Scientific title
Advisor High Density (HD) Grid Mapping Catheter Observational Study
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Secondary ID [1]
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ABT-CIP-10257
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Persistent Atrial Fibrillation
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Ventricular Tachycardia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of Subjects With Acute Success
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Assessment method [1]
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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).
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Timepoint [1]
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Immediate post procedure
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Primary outcome [2]
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Rate of Subjects With Long-term Success
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Assessment method [2]
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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.
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Timepoint [2]
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PersAF (12 months), VT (6-months)
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Secondary outcome [1]
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Overall Procedure Time
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Assessment method [1]
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Overall procedure time is defined as time from initial catheter insertion to final catheter removal.
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Timepoint [1]
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During procedure
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Secondary outcome [2]
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Radiofrequency (RF) Time
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Assessment method [2]
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Defined as duration of time RF energy is delivered
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Timepoint [2]
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During Procedure
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Secondary outcome [3]
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Fluoroscopy Time
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Assessment method [3]
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Defined as total time subject is exposed to fluoroscopy
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Timepoint [3]
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During Procedure
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Secondary outcome [4]
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Mapping Time Associated With Mapping Arrhythmia
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Assessment method [4]
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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)
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Timepoint [4]
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During Procedure
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Secondary outcome [5]
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Number of Mapping Points Collected
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Assessment method [5]
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Defined as total number of mapping points collected for the creation of each map.
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Timepoint [5]
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During Procedure
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Secondary outcome [6]
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Number of Used Mapping Points Per Minute
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Assessment method [6]
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Defined as the total number of mapping points used divided by the relative mapping time
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Timepoint [6]
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During Procedure
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Secondary outcome [7]
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Substrate Characteristics Identified
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Assessment method [7]
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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.
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Timepoint [7]
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During Procedure
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Secondary outcome [8]
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Map Type Used to Define Ablation Strategy
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Assessment method [8]
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Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.
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Timepoint [8]
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During Procedure
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Secondary outcome [9]
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Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.
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Assessment method [9]
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Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.
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Timepoint [9]
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During Procedure
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Secondary outcome [10]
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Maneuverability of HD Grid Catheter
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Assessment method [10]
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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.
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Timepoint [10]
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During Procedure
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Secondary outcome [11]
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HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms
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Assessment method [11]
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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.
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Timepoint [11]
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During Procedure
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Secondary outcome [12]
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Ablation Strategy(s) Used for PersAF Subjects
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Assessment method [12]
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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)
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Timepoint [12]
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During Procedure
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Secondary outcome [13]
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Ablation Strategy(s) Used for VT Subjects
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Assessment method [13]
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Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT.
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Timepoint [13]
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During the Procedure
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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%
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/05/2021
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Sample size
Target
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Accrual to date
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Final
379
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Recruitment in Australia
Recruitment state(s)
NSW,QslndSA,Victor
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment hospital [2]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [3]
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Flinders Private Hospital - Bedford Park
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Recruitment hospital [4]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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2066 - Melbourne
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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L Austr
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Austria
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Upper Austria
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Canada
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State/province [3]
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Arhus
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France
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State/province [7]
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Alsace
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France
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Auvergn
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France
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State/province [9]
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ILE
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Germany
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State/province [10]
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Bavaria
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Country [11]
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Germany
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State/province [11]
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N. Rhin
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Country [12]
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Germany
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State/province [12]
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Saxony
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Country [13]
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Germany
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State/province [13]
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Hamburg
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Italy
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State/province [14]
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Lombard
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Italy
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Piedmonte
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Netherlands
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State/province [16]
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Zuid
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Portugal
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State/province [17]
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Lisbon
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South Africa
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State/province [18]
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Cape Town
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Spain
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Cantabr
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Spain
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State/province [20]
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Catalon
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03733392
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT03733392/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT03733392/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03733392