IntellaTip MiFi XP Ablation Catheter Trial | NCT01730807

Studies
IntellaTip MiFi XP Ablation Catheter Trial

NCT01730807

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

May 4, 2017Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Atrial Flutter

Interventions

IntellaTip MiFi XP Catheter

Countries

Australia

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

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Nov 16, 2012

First Submission Date that Met QC Criteria

Nov 20, 2012

First Posted Date

Nov 21, 2012Estimated

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

May 2, 2017

Last Update Posted Date

May 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

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

Description Module

Brief Summary

A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

Detailed Description

A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IntellaTip XP MiFi	Experimental	Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter	Device: IntellaTip MiFi XP Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IntellaTip MiFi XP Catheter	Device	Temperature controlled ablation catheter	IntellaTip XP MiFi

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute Procedural Success	The Demonstration of bi-directional isthmus block at the end of the ablation procedure	one day

Secondary Outcomes

Measure	Description	Time Frame
Complication Rate at procedure	Determine major complications in patients exposed to the device, which occur within 7 days of the procedure	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 or older
indicated for ablation for Atrial Flutter

Exclusion Criteria:

Thrombus
Recent MI/cardiac revascularization
Prosthetic Valves
recent ablation for atrial flutter
atrial flutter with reversible cause
Class IV HF

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prashanthan Sanders, MD	Royal Adelaide Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Adelaide Hospital		Adelaide	South Australia	5001	Australia

Condition Browse Module

MeSH Terms

ID	Term
D001282	Atrial Flutter

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided