NCT02656537

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.5 years

First QC Date

November 16, 2015

Last Update Submit

January 31, 2019

Conditions

Non-paroxysmal Atrial FibrillationLeft Atrial Tachycardia

Outcome Measures

Primary Outcomes (3)

  • Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system.

    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.

    Within 48 hours from Procedure

  • 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.

    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.

    During Procedure

  • Catheter performance during the mapping portion of the procedure

    To assess the HD Grid Catheter mapping system for acceptable geometry creation, map repeatability and electrogram signal quality.

    During Procedure

Study Arms (1)

EnSite™ HD Grid Catheter AF/AT Mapping

EXPERIMENTAL
Device: EnSite™ HD Grid Catheter mapping system

Interventions

EnSite™ HD Grid Catheter mapping systemDEVICE
EnSite™ HD Grid Catheter AF/AT Mapping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Secondary atrial fibrillation (AF)
  • Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator
  • Active systemic infection (e.g. sepsis)
  • Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach
  • Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor)
  • History of cerebrovascular accidents (Stroke, TIA)
  • 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
  • Left atrial size \>55mm
  • NYHA (New York Heart Association Classification) functional class III or IV heart failure
  • Left ventricular ejection fraction \<35%
  • Uncontrolled Hyperthyroidism
  • Pregnant or of childbearing potential and not using adequate contraceptive methods or nursing
  • Participating in another clinical investigation that may confound the results of this clinical investigation
  • Life expectancy less than 12 months, as determined by Study Investigator
  • Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study Investigator, excludes the participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Royal Adelaide Hospital

Adelaide, Australia

Location

Ashford Hospital

Ashford, 5035, Australia

Location

Royal Melbourne Hospital

Parkville, 3050, Australia

Location

Hôpital du Haut Lévêque

Pessac, 33604, France

Location

Herzzentrum Dresden GmbH Universitatsklinik

Dresden, 01307, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

San Donato Hospital

Milan, Italy

Location

Study Officials

  • Carlo Pappone, MD, PhD

    San Donato Hospital, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

January 15, 2016

Study Start

August 1, 2015

Primary Completion

February 1, 2018

Study Completion

August 1, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

DE(1)FR(1)AU(3)HK(1)IT(1)