The Ohio State University 473 West 12th Ave.
Columbus, Ohio, 43210, United States
Completed
NCT Number: NCT02179203
Changes in Doppler Signals From the Lung Due to Cardiac Resynchronization in Heart Failure Patients
Study Purpose and Rationale The purpose of this study is to evaluate the lung Doppler signals changes during cardiac resynchronization procedure. As the LDS represent the various mechanical events of cardiac origin it is assumed that they may reflect the relative timing between contraction of the ventricles and atria and thus serve for effective synchronization of these activities.
Aim of the study:
The aim of the study is to assess whether the changes in Lung Doppler Signal (LDS) waves' characteristics will mimic the changes in echocardiographic parameters designed to assess diastolic inflow and systolic flow in patients undergoing Echo-based CRT optimization.
Completed
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male and female patients 18 years or older, who met the indications for cardiac synchronization therapy (CRT) per the ACCF/AHA guidelines, underwent successful system implant for more than 3 months, and were referred to the CRT non-responder clinic at the Ohio State University for CRT- Echo optimization due to absence of clinical improvement in functional class or ejection fraction after the implant per the judgment of the referring physician.
Exclusion criteria
- Chronic atrial fibrillation or new cardiac arrhythmias detected at the time of the visit that are known to affect the response to CRT (Atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or frequent premature ventricular contractions).
- CRT device malfunction
- Inadequate CRT programming that has contributed to lack of response to CRT
- Coronary sinus lead anatomical or electrical malfunctions at the time of the visit
- Acute systemic illness that can explain their lack of functional improvement (i.e., anemia, severe electrolyte imbalance, pneumothorax, pericardial effusion, pneumonia)
- Inability to sign informed consent
Treatment and study plan
Primary outcomes
-
Change in Doppler signals before and after CRT
Time frame: During procedure
Sponsors and collaborators
Lead sponsor
Echosense Ltd.
Industry
Registry information
Official study title
Lung Doppler Signals Changes in Response to Cardiac Resynchronization in Heart Failure Patients
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jul 1, 2014
- Registry last updated
- Aug 13, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.