Dipole Density Mapping of Right and Left Atrial Supravent... | NCT01914575

Studies
Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia

NCT01914575

Sponsor

Acutus Medical

Status

Withdrawn

Last Update Posted

Jan 31, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Supraventricular Tachycardia

Interventions

Mapping with the Acutus Medical System followed by Ablation

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Site never got up and running due to institutional issues

Expanded Access Info

Start Date

Jan 22, 2014Estimated

Primary Completion Date

May 16, 2016Actual

Completion Date

May 16, 2016Actual

First Submitted Date

Jul 31, 2013

First Submission Date that Met QC Criteria

Jul 31, 2013

First Posted Date

Aug 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2019

Last Update Posted Date

Jan 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dipole Density Mapping	Experimental		Device: Mapping with the Acutus Medical System followed by Ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mapping with the Acutus Medical System followed by Ablation	Device		Dipole Density Mapping

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients with device-related complications		7 days
The number of patients for which activation maps can be created		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18 to 75 years
scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
able and willing to give informed consent

Exclusion Criteria:

implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
myocardial infarction within the prior two months
cardiac surgery within the prior three months
intracardiac thrombus
clinically significant tricuspid valve regurgitation or stenosis
any cerebral ischemic event in the prior six months
pregnant or nursing
currently enrolled in any other clinical investigation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Keane, MD	St Vincent's University Hospital, Ireland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Vincent's University Hospital		Dublin			Ireland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013617	Tachycardia, Supraventricular

Ancestor Terms

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided