NCT03789487

Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause. The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.

Detailed description

This study is non-randomized, prospective, interventional, multicentric study. Patients who have been implanted with a CRT device between 6 and 18 months prior to inclusion and are considered non-responders are eligible for this study. CRT non-response can be clinical (lack of functional improvement or hospitalization for heart failure) and/or echocardiographic (insufficient improvement of LVEF and/or reduction of LVESV). Among exclusion criteria, permanent atrial fibrillation is of note. Recruited patients will be submitted to an optimization procedure of their CRT device settings. This will be performed with a non-invasive method using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings. The first step will be to chose the best pacing vector. The second step will be to chose the best AV delay. The best setting, i.e. associated with the highest blood pressure, will be programmed at the end of the optimization protocol. The patients will be followed at 6 months with clinical evaluation and echocardiography to assess the conversion rate of non-responders to responders.

Conditions

• Heart Failure
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	Device programming of CRT pacemaker or defibrillator	Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device

Timeline

• Start date: 2019-02-22
• Primary completion: 2020-08-21
• Completion: 2020-09-14
• First posted: 2018-12-28
• Last updated: 2021-01-27

Locations

3 sites across 1 country: France