Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication (CRTICD Dual LV)
|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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415024
|Contact: Wolfgang Kranig, MDfirstname.lastname@example.org|
|Contact: Rainer Grove, MDemail@example.com|
|Bad Rothenfelde, Niedersachsen, Germany, 49214|
|Contact: Wolfgang Kranig, MD +49-5424-6410 firstname.lastname@example.org|
|Contact: Rainer Grove, MD +49-5424-6410 email@example.com|
|Principal Investigator:||Wolfgang Kranig, MD||Schuechtermann-Klinik|