EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant (Bi-VNavX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01615835|
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Other: EnSite NavX System||Not Applicable|
To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Other: EnSite NavX System
- Determine feasibility of CS mapping with EnSite NavX during CRT implant [ Time Frame: Procedural ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615835
|United States, Georgia|
|Medical College of Georgia|
|Augusta, Georgia, United States, 30912|
|United States, North Carolina|
|Duke Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Adam Berman, MD||Augusta University|