Status:
UNKNOWN
A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.
Lead Sponsor:
University Medical Center Groningen
Conditions:
Heart Failure With Intraventricular Conduction Delay
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- NYHA class II-III.
- Left ventricular ejection fraction ≤ 35%.
- QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology.
- No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
- On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists.
- Age ≥ 18 years.
- Signed informed consent.
- Exclusion criteria
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Coronary ischemia or a recent myocardial infarction (\< 6 months).
- Allready a CRT-device implanted.
- Venous thrombosis without options to reach the right heart.
- Presence of any other condition than HF with a life expectancy of \< 1 year.
- History of intrathoracic surgery.
- Presence or suspected presence of a noncompliant left lung.
- Participation in another intervention trial.
- Unable to understand Dutch language.
- Pregnant women.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02247817
Start Date
October 1 2014
Last Update
September 25 2014
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