Changes in Doppler Signals From the Lung Due to Cardiac Resynchronization in Heart Failure Patients

Lung Doppler Signals Changes in Response to Cardiac Resynchronization in Heart Failure Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02179203

Enrollment

Registered

2014-07-01

Start date

2014-07-31

Completion date

2015-08-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Change in LDS Signals Due to Cardiac Synchronization Therapy

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

1. 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). 2. CRT device malfunction 3. Inadequate CRT programming that has contributed to lack of response to CRT 4. Coronary sinus lead anatomical or electrical malfunctions at the time of the visit 5. Acute systemic illness that can explain their lack of functional improvement (i.e., anemia, severe electrolyte imbalance, pneumothorax, pericardial effusion, pneumonia) 6. Inability to sign informed consent

Design outcomes

Primary

Measure	Time frame
Change in Doppler signals before and after CRT	During procedure

Countries

United States

Outcome results