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

NCT02179203 | Completed

• 1 other identifier: DOP021
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Change in LDS Signals Due to Cardiac Synchronization Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Doppler signals before and after CRT

  During procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for cardiac snchronization therapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Echosense Ltd.: lead

Study Sites (1)

The Ohio State University 473 West 12th Ave.

Columbus, Ohio, 43210, United States

Location

Study Officials

• Hyesha Hasan, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2014-06

Locations

US (1)