Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

NCT03789487 | Terminated

• 1 other identifier: 2018/09
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Heart Failure; Cardiac Resynchronization Therapy

Keywords

Cardiac Resynchronization Therapy; Non-responders; Pacing vector optimization; Atrioventricular delay optimization; Non invasive hemodynamic optimization; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Hemodynamic response

  Highest Systolic Blood Pressure (SBP) obtained by stimulation vector

  During the optimization session

Secondary Outcomes (2)

• echocardiographic response

  at 6 months of follow-up

• Clinical response

  at 6 months of follow up

Study Arms (1)

Non-responders to CRT

EXPERIMENTAL

Non-responders to CRT who will undergo an electrical optimization of the settings of their device

Device: Device programming of CRT pacemaker or defibrillator

Interventions

Device programming of CRT pacemaker or defibrillator DEVICE

Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device

Non-responders to CRT

Eligibility Criteria

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

You may qualify if:

• Patient older than 18
• Non-responder patients:
• Clinical criteria (Packer classification):
• Lack of improvement of NYHA functional class And/or hospitalization for heart failure
• Echocardiographic criteria:
• Lack of improvement of LVEF \> 5points And/or reduction of LVESV \< 15%
• Patient who had signed an informed consent and is willing to comply with study requirements
• Patient covered by French national healthcare insurance

You may not qualify if:

• Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
• Scheduled hospitalization for major cardiac intervention or cardiac surgery in the 6 coming months
• Life-expectancy of less than 6 months
• Pregnant or breastfeeding women
• Adults under legal protection

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (3)

GHEM Eaubonne

Montmorency, 95160, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 28, 2018
• Study Start: February 22, 2019
• Primary Completion: August 21, 2020
• Study Completion: September 14, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)