Clinical trial NCT03779802: Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients
Official title: Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Keywords: Cardiac Resynchronization Therapy
Atrioventricular delay optimization
Multipoint pacing
Negative atrioventricular hysteresis
Non invasive hemodynamic optimization
Heart Failure
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemodynamic response
timeFrame: day 0
Secondary outcomes:
measure: Other hemodynamical response
timeFrame: day 0
measure: Other hemodynamical response
timeFrame: day 0
measure: Other hemodynamical response
timeFrame: day 0
Other outcomes:
Locations:
city: Eaubonne
country: France
facility: Gehm Site D'Eaubonne
state: Val-d'Oise
city: Neuilly sur seine
country: France
facility: Cmc Ambroise Pare
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: CMC Ambroise Paré
name: Ghassan MD MOUBARAK
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.