NCT01615835

EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant

Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
OTHER	EnSite NavX System	EnSite NavX system is a 3D Mapping system

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2012-06-11
• Last updated: 2019-02-04

Locations

2 sites across 1 country: United States