NCT03779802

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-23
• Primary completion: 2020-04-18
• Completion: 2020-04-18
• First posted: 2018-12-19
• Last updated: 2026-04-07

Locations

3 sites across 1 country: France