Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601322
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony FOCUS-Right
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study FOCUS-Right
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOCUS-Right
Brief Summary:
The goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance CPET-CMR and cardiopulmonary exercise testing in patients with pre-existing left bundle branch area pacemakers LBBAP programmed to an atrial sensing mode Measurements of right ventricular left ventricular function and exercise capacity will be obtained at various LBBAP programming parameters at rest and during low intensity exercise The main aims of the study are
Demonstrate the safety and feasibility of performing CPET-CMR in patients with pre-existing LBBAP programmed to P-synchronous ventricular pacing mode
Generate preliminary data evaluating differences in RV function LV function and exercise capacity during various pacemaker programming settings
Demonstrate the safety and feasibility of performing CPET-CMR in patients with pre-existing LBBAP programmed to P-synchronous ventricular pacing mode
Generate preliminary data evaluating differences in RV function LV function and exercise capacity during various pacemaker programming settings
Detailed Description:
Conduction system pacing namely left bundle branch area pacing LBBAP represents an important pacing modality introduced to avoid the deleterious effects of non-physiologic ventricular activation during chronic right ventricular pacing and or left bundle branch block LBBBP Previous studies have demonstrated that LBBAP exhibits similar or superior left ventricular resynchronization compared to conventional treatment modalities the impact of this novel pacing strategy on the right ventricle has not yet been addressed This study aims to demonstrate the safety and feasibility of assessing LBBAP performance with a focus on right ventricular function in a novel way utilizing Cardiopulmonary Exercise Testing and Exercise Stress Cardiac Magnetic Resonance
The investigators plan a 1-day prospective non-randomized controlled pilot study in which up to 20 subjects with left bundle branch area pacemakers with evidence of output dependent anodal capture will undergo low intensity exercise CPET-CMR at three different LBBAP settings underlying rhythm non-selective left bundle pacing non-selective left bundle pacing with anodal stimulation
The investigators plan a 1-day prospective non-randomized controlled pilot study in which up to 20 subjects with left bundle branch area pacemakers with evidence of output dependent anodal capture will undergo low intensity exercise CPET-CMR at three different LBBAP settings underlying rhythm non-selective left bundle pacing non-selective left bundle pacing with anodal stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None