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Persistent Atrial FibrillationNCT03733392

Advisor HD Grid Observational Study

An observational study of Persistent Atrial Fibrillation and Ventricular Tachycardia, run by Abbott Medical Devices at 25 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Advisor HD Grid Mapping Catheter, Sensor Enabled
Type of treatment
Medical device
How many people
379 participants
Where
25 sitesin 11 countries
Study dates
11 Jan 2019to 27 May 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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:
  • 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

Who cannot join

  • 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)
Show all 18Show fewer
  • 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:
  • PersAF: i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause.
  • 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).
  • 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%
  • -

Trial locations and contacts

25 sites in 11 countries.

25 sites in 11 countries

Germany5 sites

  • Medizinische Einrichtungen der Universität zu Köln

    Cologne, N. RHIN

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden, Saxony, 1397

  • Klinikum Fürth

    Fürth, Bavaria

  • UKE Hamburg (Universitatsklinik Eppendorf)

    Hamburg, 20246

  • Herzzentrum Leipzig GmbH

    Leipzig, Saxony, 4289

Other trials in Germany

Australia4 sites

  • Flinders Private Hospital

    Bedford Park, South Australia, 5042

  • The Prince Charles Hospital

    Chermside, Qslnd, 4032

  • Monash Medical Centre

    Clayton, Victori, 3168

  • The Alfred Hospital

    Melbourne, New South Wales, 2066

Other trials in Australia

Canada3 sites

  • Institut de Cardiologie de Quebec (Hôpital Laval)

    Québec, Quebec, G1V 4G5

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Paul's Hospital

    Vancouver, British Columbia, V6E1M7

Other trials in Canada

France3 sites

  • Pole Sante Republique

    Clermont-Ferrand, Auvergn, 63050

  • Institute Cardio. Paris-Sud - Institut Jacques Cartier

    Massy, ILE, 91300

  • Clinique Rhena

    Strasbourg, Alsace, 67200

Other trials in France

Austria2 sites

  • A. ö. Krankenhaus der Elisabethinen Linz

    Linz, Upper Austria, 4020

  • KH Wiener Neustadt

    Wiener Neustadt, L Austr, 2700

Other trials in Austria

Italy2 sites

  • Ospedale Cardinal Massaia Di Asti

    Asti, Piedmonte, 1411

  • Ospedale San Raffaele

    Milan, Lombard, 20132

Other trials in Italy

Spain2 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, Catalon, 8036

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabr, 8036

Other trials in Spain

Denmark1 site

  • Skejby University Hospital

    Aarhus, 8200

Other trials in Denmark

Netherlands1 site

  • Haga Ziekenhuis Locatie Leyenburg

    The Hague, ZUID, 2545AA

Other trials in Netherlands

Portugal1 site

  • Santa Maria Hospital

    Lisbon, Lisbon District, 1070-313

Other trials in Portugal

South Africa1 site

  • Christiaan Barnard Memorial Hospital

    Cape Town, 8001

Other trials in South Africa

About this study

Official title: Advisor High Density (HD) Grid Mapping Catheter Observational Study

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.

Being tested
Advisor HD Grid Mapping Catheter, Sensor Enabled
Medical subject headings
Atrial Fibrillation, Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advisor HD Grid Mapping Catheter, Sensor EnabledDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Subjects With Acute Success

    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).

    Measured: Immediate post procedure

  2. Rate of Subjects With Long-term Success

    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.

    Measured: PersAF (12 months), VT (6-months)

Secondary outcomes (13)

  1. Overall Procedure Time

    Overall procedure time is defined as time from initial catheter insertion to final catheter removal.

    Measured: During procedure

  2. Radiofrequency (RF) Time

    Defined as duration of time RF energy is delivered

    Measured: During Procedure

  3. Fluoroscopy Time

    Defined as total time subject is exposed to fluoroscopy

    Measured: During Procedure

  4. Mapping Time Associated With Mapping Arrhythmia

    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)

    Measured: During Procedure

  5. Number of Mapping Points Collected

    Defined as total number of mapping points collected for the creation of each map.

    Measured: During Procedure

  6. Number of Used Mapping Points Per Minute

    Defined as the total number of mapping points used divided by the relative mapping time

    Measured: During Procedure

  7. Substrate Characteristics Identified

    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.

    Measured: During Procedure

  8. Map Type Used to Define Ablation Strategy

    Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.

    Measured: During Procedure

  9. Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.

    Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.

    Measured: During Procedure

  10. Maneuverability of HD Grid Catheter

    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.

    Measured: During Procedure

  11. HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms

    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.

    Measured: During Procedure

  12. Ablation Strategy(s) Used for PersAF Subjects

    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)

    Measured: During Procedure

  13. Ablation Strategy(s) Used for VT Subjects

    Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT.

    Measured: During the Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start11 Jan 2019
  3. Primary completion27 May 2021
  4. Study completion27 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733392
Sponsor's protocol ID
ABT-CIP-10257
Status last verified
Apr 2024
First submitted
30 Oct 2018
Last updated
16 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Persistent Atrial Fibrillation and Ventricular Tachycardia, run by Abbott Medical Devices at 25 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Germany, Australia, Canada, France, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Subjects With Acute Success (time frame: Immediate post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03733392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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