NCT03803826

Cardiac Strains for Optimization of CRT in Non-Responders

Use of Cardiac Strains for Optimization of Cardiac Resynchronization Therapy in Non-Responders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the possibility of optimizing the performance of CRT-D in non-responding patients through utilization of cardiac strain speckle tracking

Detailed description

In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to any improvement of the patients' status. In this study, an investigation of a possible method of optimization through speckle tracking of cardiac strains is attempted. Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap and the interventricular interval subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and use of other strain combinations assessed.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DEVICE	CRT-D re-programming	The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to: 1. adjust the atrioventricular interval so that E and A waves do not overlap 2. the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.
DIAGNOSTIC_TEST	Trans-Thoracic Echocardiography	This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing.

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2019-01-15
• Last updated: 2022-12-07

Locations

1 site across 1 country: Czechia