Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication (CRTICD Dual LV)
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|ClinicalTrials.gov Identifier: NCT01415024|
Recruitment Status : Unknown
Verified August 2011 by Schuechtermann-Klinik.
Recruitment status was: Recruiting
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. However, the physiological agitation of the left ventricle takes place over two pathways. Therefore single point stimulation might be insufficient for a dilated, insufficiently and asynchronously contracting left ventricle, resulting in either insufficient or no response to the therapy.
In the "CRT ICD Dual LV" study the patients receive a second LV lead in an anterior vein. When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both leads permanently. If not they will be stimulated conventionally.
The patients participating in this study are monitored for 12 months after implantation.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Left Bundle-Branch Block||Procedure: second LV lead in CRT||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Resynchronization in Paced Heart Failure Patients With ICD Indication|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||May 2012|
- Procedure: second LV lead in CRT
second LV lead in CRT
- LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing [ Time Frame: Implantation with pressure measurement will take place in the first week ]
- Leftventricular endsystolic volume [ Time Frame: 12 month ]
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): NCT01415024
|Contact: Wolfgang Kranig, MDemail@example.com|
|Contact: Rainer Grove, MDfirstname.lastname@example.org|
|Bad Rothenfelde, Niedersachsen, Germany, 49214|
|Contact: Wolfgang Kranig, MD +49-5424-6410 email@example.com|
|Contact: Rainer Grove, MD +49-5424-6410 firstname.lastname@example.org|
|Principal Investigator:||Wolfgang Kranig, MD||Schuechtermann-Klinik|