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EnSite™ HD Grid Catheter AF/AT Mapping Study

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ClinicalTrials.gov Identifier: NCT02656537
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).

Condition or disease Intervention/treatment Phase
Non-paroxysmal Atrial Fibrillation Left Atrial Tachycardia Device: EnSite™ HD Grid Catheter mapping system Not Applicable

Detailed Description:

Catheter ablation for non-paroxysmal AF is more complex as triggers, if present at all, are not immediately apparent, but the abnormal atrial substrates are the likely predominant mechanisms. Additional catheter ablation strategies targeting for atrial substrate modification have been introduced. The common strategies involve either application of empirical linear lesion sets in the atrial areas or ablation of atrial areas with complex fractionated atrial electrograms in addition to pulmonary vein isolation. Nevertheless, the corresponding success rates in long-term sinus rhythm maintenance are modest.

Non-paroxysmal AF and left AT are characterized by fast and regular atrial activities, complex fractionated atrial electrograms, consistent direction of wave front propagation, and low peak-to-peak voltage. Advanced high-density three-dimensional catheter mapping strategies to target the evaluation of these characteristics and mechanisms responsible for the AF and left AT, identification of atrial areas with low peak-to-peak voltages and determination of the "critical" atrial targets for catheter ablation during the procedures would be essential.

In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal AF or left AT.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia
Actual Study Start Date : August 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EnSite™ HD Grid Catheter AF/AT Mapping Device: EnSite™ HD Grid Catheter mapping system



Primary Outcome Measures :
  1. Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system. [ Time Frame: Within 48 hours from Procedure ]
    To evaluate the safety of the novel EnSite™ HD Grid Catheter mapping system by collecting intra- and post-Procedure (within 48 hours from Procedure) adverse events.

  2. Number of subjects with the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation studied using the EnSite™ HD Grid Catheter mapping system. [ Time Frame: During Procedure ]
    To identify and study the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation using a novel EnSite™ HD Grid Catheter mapping system.

  3. Catheter performance during the mapping portion of the procedure [ Time Frame: During Procedure ]
    To assess the HD Grid Catheter mapping system for acceptable geometry creation, map repeatability and electrogram signal quality.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT) referred for catheter ablation
  2. Age of 18 years of age or older at time of Enrollment
  3. On continuous anticoagulation (INR 2-3) for >4 weeks prior to the ablation
  4. Able and willing to provide written informed consent to participate in this clinical investigation

Exclusion Criteria:

  1. Secondary atrial fibrillation (AF)
  2. Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator
  3. Active systemic infection (e.g. sepsis)
  4. Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach
  5. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor)
  6. History of cerebrovascular accidents (Stroke, TIA)
  7. Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass <180 days at Enrollment or cardiovascular intervention expected in the 180 days post-Enrollment
  8. Left atrial size >55mm
  9. NYHA (New York Heart Association Classification) functional class III or IV heart failure
  10. Left ventricular ejection fraction <35%
  11. Uncontrolled Hyperthyroidism
  12. Pregnant or of childbearing potential and not using adequate contraceptive methods or nursing
  13. Participating in another clinical investigation that may confound the results of this clinical investigation
  14. Life expectancy less than 12 months, as determined by Study Investigator
  15. Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study Investigator, excludes the participation in the study

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): NCT02656537


Locations
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Australia
Royal Adelaide Hospital
Adelaide, Australia
Ashford Hospital
Ashford, Australia, 5035
Royal Melbourne Hospital
Parkville, Australia, 3050
France
Hôpital du Haut Lévêque
Pessac, France, 33604
Germany
Herzzentrum Dresden GmbH Universitatsklinik
Dresden, Germany, 01307
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Italy
San Donato Hospital
Milan, Italy
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Carlo Pappone, MD, PhD San Donato Hospital, Italy

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02656537     History of Changes
Other Study ID Numbers: CRD772
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease