A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.
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|ClinicalTrials.gov Identifier: NCT02247817|
Recruitment Status : Unknown
Verified September 2014 by Jasper J. Schouwenburg, University Medical Center Groningen.
Recruitment status was: Not yet recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
University Medical Center Groningen
Information provided by (Responsible Party):
Jasper J. Schouwenburg, University Medical Center Groningen
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 a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Intraventricular Conduction Delay||Device: Hybrid CRT-D/P implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2014|
Hybrid transvenous/epicardial implantation of a CRT-(D) device.
Device: Hybrid CRT-D/P implantation
Primary Outcome Measures :
- Number of procedure related serious adverse events [ Time Frame: 30 days after implantation of device ]
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