EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/6/2019 |
| Start Date: | April 2007 |
| End Date: | October 2007 |
Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
Use of the EnSite NavX system to map the coronary vasculature during CRT implant
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.
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.
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
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