Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients

Not Applicable

Terminated

• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Interventions: Other: Device programming of ABBOTT CRT pacemaker or defibrillator

• Registration Number: NCT03779802
• Lead Sponsor: CMC Ambroise Paré

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.

Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.

The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.

Detailed Description

This study is a non-randomized, prospective, interventional, multicentric study.

Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months are eligible for the study.

Recruited patients will be submitted to a non-invasive evaluation of different pacing modes. This will be performed 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

Three modes of stimulation of ABBOTT CRT devices will be compared:

* Classical bi-ventricular pacing mode at nominal value and with AV delay optimization

* SyncAV mode at nominal value or with left ventricular preexcitation optimization

* Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute evaluation study without scheduled follow-up.

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-04-23
• Status Verified: 2020-04
• Primary Completion: 2020-04-18
• Study Completion: 2020-04-18
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patient older than 18
• Implantation of a CRT (CRT-P or CRT-D) less than 3 months before inclusion
• MPP and SyncAV-enabled ABBOTT Quadripolar CRT pacing system
• Patient who had signed an informed consent and is willing to comply with study requirements
• De novo implantation
• Patient covered by national healthcare insurance

Exclusion Criteria

• Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
• Pacing indication for 2nd or 3rd degree AV block
• Upgrading from non-CRT system
• Pregnant or breastfeeding women
• Adult under legal protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT device	Device programming of ABBOTT CRT pacemaker or defibrillator	Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes

Primary Outcome Measures

Name	Time	Method
Hemodynamic response	day 0	Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation

Secondary Outcome Measures

Name	Time	Method
Other hemodynamical response	day 0	dP/dT

Trial Locations

Locations (3)

Gehm Site D'Eaubonne; 🇫🇷 Eaubonne, Val-d'Oise, France

Cmc Ambroise Pare; 🇫🇷 Neuilly sur seine, France

CHU Poitiers; 🇫🇷 Poitiers, France