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Prevalence of Atrial Delay That Would Preclude Optimization of Atrioventricular (AV) Delay in Patients With Biventricular (BiV) Device

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906100
First Posted: May 21, 2009
Last Update Posted: May 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
  Purpose
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.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Prolonged Inter/Intra-Atrial Delay That Would Preclude Optimization of Atrioventricular (AV) Delay in Patients Undergoing Biventricular (BiV) Device Placement

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for biventricular ICD placement
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Carol Nguyen    214-590-5015    Carol.Nguyen@UTSouthwestern.edu   
Principal Investigator: Owen Obel         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Owen Obel UT Southwestern Medical Center
  More Information

Responsible Party: Owen Obel, MD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00906100     History of Changes
Other Study ID Numbers: UTSW IRB 122007-040
First Submitted: May 19, 2009
First Posted: May 21, 2009
Last Update Posted: May 21, 2009
Last Verified: May 2009

Keywords provided by University of Texas Southwestern Medical Center:
Biventricular ICD
AV delay

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases