Prevalence of Atrial Delay That Would Preclude Optimization of Atrioventricular (AV) Delay in Patients With Biventricular (BiV) Device
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|ClinicalTrials.gov Identifier: NCT00906100|
Recruitment Status : Withdrawn (Dr Obel is deceased and no other investigators on study to provide information. old record, IRB has no information; outside of retention period.)
First Posted : May 21, 2009
Last Update Posted : February 7, 2019
|Condition or disease|
This is a prospective observational study. Patients referred for BiV-ICD implantation or upgrade will be implanted as is routinely done, with the following modifications:
- Electrical readings will be taken at various points in the procedure.
- The RA lead will temporarily be placed on the atrial septum for these readings (normally it is actively fixed to the RA appendage wall). The final RA lead position will be actively fixed to the RA appendage wall as is standard practice.
- The CS lead will be placed in the proximal coronary sinus for these readings prior to passing it distally to pace the LV.
- Patients will undergo transthoracic echocardiography (TTE) 30 days post-procedure. This will be coordinated to coincide with their standard 30-day follow-up appointment.
Conduction times between the left atrium and right atrium (inter-atrial conduction time) will be measured at the time of implant, and left atrial contraction time will be measured by TTE at the follow-up appointment. For patients in whom the inter-atrial conduction time plus the left atrial contraction time is greater than the right-atrial to right-ventricular conduction time, it is not possible to optimize the AV delay. The proportion of patients who fall into this group will be the main endpoint of the study. Patients will be followed for this study until their follow-up appointment and TTE at 30 days post-implant. The total sample size of this study will be 50 patients. We expect to consent approximately 75 patients, expecting that 1/3 will not meet all entrance criteria or will withdraw early.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Prevalence of Prolonged Inter/Intra-Atrial Delay That Would Preclude Optimization of Atrioventricular (AV) Delay in Patients Undergoing Biventricular (BiV) Device Placement|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2010|
- to determine the proportion of patients who are undergoing Biventricular (BiV) Implantable Cardioverter Defibrillator (ICD) implantation in whom optimization of atrioventricular (AV) delay is not possible due to prolonged inter-atrial/intra-atrial delay.
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): NCT00906100
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Owen Obel||UT Southwestern Medical Center|