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 because the information has not been verified recently.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00906100
First received: May 19, 2009
Last updated: May 20, 2009
Last verified: May 2009
  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. [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Owen Obel, MD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00906100     History of Changes
Other Study ID Numbers: UTSW IRB 122007-040
Study First Received: May 19, 2009
Last Updated: May 20, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014