Trials Sponsors Conditions Drugs Pricing

Conditions

Left Atrial Tachycardia Non-paroxysmal Atrial Fibrillation

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (7)

Royal Adelaide Hospital

Adelaide, Australia

Ashford Hospital

Ashford, 5035, Australia

Royal Melbourne Hospital

Parkville, 3050, Australia

Hôpital du Haut Lévêque

Pessac, 33604, France

Herzzentrum Dresden GmbH Universitatsklinik

Dresden, 01307, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

San Donato Hospital

Milan, Italy

Study Officials

Carlo Pappone, MD, PhD
San Donato Hospital, Italy
PRINCIPAL INVESTIGATOR

Enrollment

82 participants (actual enrollment reported by the registry).

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 2015

Actual (reported)

EnSite™ HD Grid Catheter AF/AT Mapping Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

EnSite™ HD Grid Catheter AF/AT Mapping

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

EnSite™ HD Grid Catheter AF/AT Mapping

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations