NCT03789487: OPTIREG

Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

Terminated NA Last updated 27 January 2021

What this trial tests

NA trial testing Device programming of CRT pacemaker or defibrillator in Heart Failure in 27 participants. Terminated before completion.

Timeline

22 February 2019

Primary endpoint
21 August 2020

14 September 2020

Quick facts

Lead sponsor	CMC Ambroise Paré
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	22 February 2019
Primary completion	21 August 2020
Estimated completion	14 September 2020
Sites	3 locations across France

Drugs / interventions tested

• Device programming of CRT pacemaker or defibrillator

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Cardiac Resynchronization Therapy — all drugs for Cardiac Resynchronization Therapy →

Sponsor

CMC Ambroise Paré — full company profile →

Who can join

18 and older, any sex, with Heart Failure or Cardiac Resynchronization Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.