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

Heart Failure Clinical Trial

— 3 STIM  

Official title:

Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03779802
• Other study ID #: 2018/10
• Status: Terminated
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: April 18, 2020

Study information

• Verified date: April 2020
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 18, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

Other:
• Device programming of ABBOTT CRT pacemaker or defibrillator
Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session.

Locations

Country	Name	City	State
France	Gehm Site D'Eaubonne	Eaubonne	Val-d'Oise
France	Cmc Ambroise Pare	Neuilly sur seine
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic response	Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation	day 0
Secondary	Other hemodynamical response	Cardiac output	day 0
Secondary	Other hemodynamical response	Systolic ejection volume	day 0
Secondary	Other hemodynamical response	dP/dT	day 0