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Advisor HD Grid Observational Study

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ClinicalTrials.gov Identifier: NCT03733392
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
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 Vmax voltage mapping (hereafter called "HD Wave") in subjects with PersAF or VT in real-world clinical settings.

Condition or disease Intervention/treatment
Persistent Atrial Fibrillation Ventricular Tachycardia Device: Advisor HD Grid Mapping Catheter, Sensor Enabled

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Advisor HD Grid Observational Study
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021



Intervention Details:
  • Device: 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.


Primary Outcome Measures :
  1. To quantify and characterize the acute- and long-term success rate of RF ablation after electroanatomical mapping with HD Grid and Ensite Precision with HD Wave in subjects with PersAF or VT. [ Time Frame: 6 months (VT) 12 months (Persistent AF) ]
    The rate of acute success is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). For PersAF, the rate of long-term success rate is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery 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 change in class I/III antiarrhythmic drug (AAD) use. For VT, the rate of long-term success is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery and have had freedom from reoccurrence of sustained monomorphic VT and a change in class I/III AAD use at 6-month follow-up.


Secondary Outcome Measures :
  1. Overall Procedure Time [ Time Frame: During procedure ]
    Defined as time from initial catheter insertion to final catheter removal

  2. Radiofrequency Time [ Time Frame: During Procedure ]
    Defined as duration of time RF energy is delivered

  3. Fluoroscopy Time [ Time Frame: During Procedure ]
    Defined as total time subject is exposed to fluorscopy

  4. Mapping Time Associated with Mapping Arrhythmia [ Time Frame: During Procedure ]
    Defined as the total cumulative mapping time and mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)

  5. Number of Mapping Points Collected [ Time Frame: During Procedure ]
    Defined as total number of mapping points collected for the creation of each map.

  6. Number of Used Mapping Points Per Minute [ Time Frame: During Procedure ]
    Defined as the total number of mapping points used divided by the relative mapping time

  7. Substrate Characteristics Identified [ Time Frame: 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.

  8. Ablation Strategy(s) Used [ Time Frame: 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.

  9. Role of HD Wave map relative to along-the-spline map in ablation strategy decision. [ Time Frame: During Procedure ]
    Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline electrode configurations.

  10. Maneuverability of HD Grid Catheter [ Time Frame: 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.

  11. HD Grid electrogram quality relative to ablation catheter electrograms [ Time Frame: 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.


Other Outcome Measures:
  1. Change in Quality of Life [ Time Frame: 6 month and 12 month ]
    Defined as change in quality of life assessed in validated QOL surveys (EQ-5D and AFEQT for subjects with PersAF, EQ-5D and HADS for subjects with VT).

  2. Rate of periprocedural and immediate post procedural (48hrs) procedure- or device- related adverse events in all subjects in whom the HD Grid is inserted. [ Time Frame: 48 hours ]
    Adverse Events

  3. Rate of procedure- or device-related adverse events and cardiovascular serious adverse events in all subjects in whom the HD Grid is inserted . [ Time Frame: 30 days ]
    Adverse Events

  4. Proportion of VT subjects who receive HD Grid mapping and RF energy delivery free from recurrence of sustained monomorphic VT and new or increased dose of class I/III AAD, and free from recurrence of sustained monomorphic VT on or off class I/III AAD. [ Time Frame: 90 days to 12 months ]
    Free from recurrence of sustained monomorphic VT on or off class I/III AADs at 12-month follow-up outside the blanking period.

  5. Rate of repeat ablations after study procedure during 12-month follow up [ Time Frame: Through 12 months ]
    Defined as proportion of subjects without an additional ablation procedure to treat indicated cardiac arrhythmia.

  6. Proportion of atypical atrial flutter identified during procedure for Persistent AF patients. [ Time Frame: During Procedure ]
    Of those receiving HD Grid mapping and RF ablation for AFL: Utility of HD Grid specific to the identification and treatment of atypical AFL, including role of HD wave relative to along-the-spline maps in identifying ablation target(s), and time of RF application to terminate atypical AFL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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 cerebroembolic 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. LAD > 55 mm (parasternal long axis view) iii. LVEF < 40% iv. Uncontrolled heart failure or NYHA function class III or IV v. Presence of implanted ICD/CRT-D. b. VT: i. VT/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%

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733392


Contacts
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Contact: Laura Menck 651-756-2375 laura.menck@abbott.com
Contact: Amber Miller 651-756-2885 amber.miller@abbott.com

Locations
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Australia, New South Wales
The Alfred Hospital Recruiting
Melbourne, New South Wales, Australia, 2066
Contact: Sonia Azzopardi         
Principal Investigator: Peter Kistler, MD         
Australia, South Australia
Flinders Private Hospital Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Christine Hinks         
Principal Investigator: Andrew McGavigan, MD         
Austria
A. ö. Krankenhaus der Elisabethinen Linz Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Claudia Steinkellner         
Principal Investigator: Georgios Kollias, MD         
France
Clinique Pasteur Toulouse Recruiting
Toulouse, Mid-Pyrenee, France, 31076
Contact: Juliette Goutner         
Principal Investigator: Jean Paul Albenque, MD         
Italy
Ospedale Cardinal Massaia Di Asti Recruiting
Asti, Piedmonte, Italy, 1411
Contact: Battaglia Alberto, MD         
Principal Investigator: Marco Scaglione, MD         
Portugal
Santa Maria Hospital Recruiting
Lisboa, Lisbon, Portugal, 1070-313
Contact: Ana Bernardes         
Principal Investigator: Joao Sousa         
South Africa
Christiaan Barnard Memorial Hospital Recruiting
Cape Town, South Africa, 8001
Contact: Mischka Lorgat         
Principal Investigator: Faizel Lorgat, MD         
Sponsors and Collaborators
Abbott Medical Devices

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03733392     History of Changes
Other Study ID Numbers: ABT-CIP-10257
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease