Prevalence of Atrial Delay That Would Preclude Optimization of Atrioventricular (AV) Delay in Patients With Biventricular (BiV) Device
| Status: | Withdrawn |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | May 2008 |
| End Date: | May 2010 |
Prevalence of Prolonged Inter/Intra-Atrial Delay That Would Preclude Optimization of Atrioventricular (AV) Delay in Patients Undergoing Biventricular (BiV) Device Placement
The purpose of this study is 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. These patients would benefit from left atrial pacing, and if
a significant number of patients fall into this group, it may be beneficial to develop a left
atrial lead.
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. These patients would benefit from left atrial pacing, and if
a significant number of patients fall into this group, it may be beneficial to develop a left
atrial lead.
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.
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.
Inclusion Criteria:
- Age 18 or older
- Have the ability to provide informed consent and willingness to comply with follow-up
tests
- QRS duration > 120 ms
- Ejection fraction < 35%
- Persistent symptoms of class III or IV heart failure despite a stable and optimized
medical regimen
- Normal sinus rhythm or sinus bradycardia
Exclusion Criteria:
- White-Parkinson-White syndrome
- Chronic persistent atrial fibrillation
- Complete heart block
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