Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03779802
Status:
TERMINATED
Last Update Posted:
2020-05-22
First Post:
2018-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients
Sponsor:
CMC Ambroise Paré
Organization:
Study Overview
Official Title:
Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
With the current health situation, we do not anticipate a significant resumption of recruitment for several months.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3 STIM
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: