EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant | NCT01615835

Studies
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant

NCT01615835

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Congestive Heart Failure

Interventions

EnSite NavX 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

Feb 2019

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

Apr 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Jun 6, 2012

First Posted Date

Jun 11, 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

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Detailed Description

Objective(s):

To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.

Inclusion Criteria:

Subject is between the age of 18 and 75 years
Subject is willing and able to sign a study specific informed consent
Subject is able to fulfill study requirements
Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV
Have persistent CHF symptoms despite contemporary CHF medical therapy
Stable and optimal medical therapy (stability is no changes in past 3 months).
Documented history of ischemic or non-ischemic cardiomyopathy.

Exclusion Criteria:

Have any standard device exclusions including tricuspid valve prosthesis/ replacement.
Have a positive urine or serum pregnancy test (if female and of childbearing potential)
Be currently participating in an IDE or IND study.

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

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EnSite NavX System	Other	EnSite NavX system is a 3D Mapping system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine feasibility of CS mapping with EnSite NavX during CRT implant		Procedural

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet criteria for CRT implant including EF<35%, QRS>120ms, NYHA class III or IV
Persistent CHF symptoms despite optimization
Stable/optimal medical therapy
History of ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

Any standard device exclusion including TVR
Positive pregnancy test
Currently participating in IDE/IND study

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
Adam Berman, MD	Augusta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical College of Georgia		Augusta	Georgia	30912	United States
Duke Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided