Gen2 Isthmus-Dependent Atrial Flutter Ablation Study | NCT00606463

Studies
Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

NCT00606463

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Jul 14, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Atrial Flutter

Interventions

Cardiac Ablation (Gen2 Cardiac Ablation System)

Countries

United States

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Abbott funding allocated to a different project.

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jan 21, 2008

First Submission Date that Met QC Criteria

Feb 1, 2008

First Posted Date

Feb 4, 2008Estimated

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

Jul 13, 2023

Last Update Posted Date

Jul 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Irrigated catheter for ablation of isthmus-dependent atrial flutter

Detailed Description

This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent 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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
(Gen2 Cardiac Ablation System)	Experimental	Ablation of isthmus-dependent atrial flutter	Device: Cardiac Ablation (Gen2 Cardiac Ablation System)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Ablation (Gen2 Cardiac Ablation System)	Device	Ablation of isthmus-dependent atrial flutter	(Gen2 Cardiac Ablation System)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of intraprocedural, serious cardiac adverse event	Defined as the Incidence of intraprocedural, serious cardiac adverse event	7 days post-procedure

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Bi-direction block and non-inducibility of atrial flutter	Acute Procedure success defined as bi-directional block and non-inducibility of atrial flutter	Procedural

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for ablation of isthmus-dependent atrial flutter

Exclusion Criteria:

Prior ablation of isthmus-dependent atrial flutter
Atypical or scar flutter
Significant heart disease
Intracardiac thrombus
Prior cardiac surgery (within 1 month)
Contraindication to heparin

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
Vance Plumb, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Birmingham		Birmingham	Alabama		United States
St. Barnabus Medical Center

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
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

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided