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NCT06044597

Post-market Prospective, Multicenter, Randomized and Single-blinded Clinical Investigation to Evaluate Whether Cardiac Re-Synchronization Therapy (CRT) Using Automatic Continuous Atrioventricular (AV) Delay Optimization is Superior to CRT With Conventional Biventricular Stimulation (BiV).

Sponsor: Antonio Rapacciuolo

View on ClinicalTrials.gov

Summary

The goal of this randomized, multicenter prospective study is to demonstrate that the activation of biventricular pacing with fusion and AV optimization feature will increase the rate of CRT responders in terms of LV reverse remodeling, compared with conventional biventricular pacing.

Official title: Post-market Prospective, Multicenter, Randomized and Single-blinded Clinical Investigation to Evaluate Whether Cardiac Re-Synchronization Therapy (CRT) Using Automatic Continuous Atrioventricular (AV) Delay Optimization is Superior to CRT With Conventional Biventricular Stimulation (BiV). (CRUSTY + Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

722

Start Date

2023-10-01

Completion Date

2026-10-30

Last Updated

2023-09-21

Healthy Volunteers

Conditions

Heart Failure

Interventions

DEVICE

SyncAV function on

CRT-D with SyncAV plus activated

Inclusion Criteria: * More than 18 years of age; * Have signed the Informed Consent form. * have been implanted with an Abbott CRT-D with the Sync-AV dynamic function under the current Class I or Class IIa ESC indications (2021 guidelines) for CRT implantation (including upgrades from single or dual chamber pacemakers or ICDs); * Have to be in sinus rhythm at the Baseline visit and with Left Branch Block (LBBB) (2021 ESC/REVERSE): * LVEF needs to be \<35% while under optimal medical treatment * to be willing to meet all study requirements and have the ability to do participate to this study. Exclusion Criteria: Inclusion / Exclusion criteria: Inclusion criteria: To participate in this clinical study, patients must meet ALL of the following inclusion criteria: * More than 18 years of age; * Have signed the Informed Consent form. * And have been implanted with an Abbott CRT-D with the Sync-AV dynamic function under the current Class I or Class IIa ESC indications (2021 guidelines) for CRT implantation (including upgrades from single or dual chamber pacemakers or ICDs); * Have to be in sinus rhythm at the Baseline visit and with Left Branch Block (LBBB) (2021 ESC/REVERSE): * LVEF needs to be \<35% while under optimal medical treatment * In addition, patients need to be willing to meet all study requirements and have the ability to do participate to this study. Exclusion criteria: Patients who meet any of the following exclusion criteria are NOT eligible to participate in the clinical study: * Having suffered a myocardial infarction or unstable angina in the 40 days prior to inclusion. * Having undergone coronary revascularization (PTCA, Stent or CABG) in the 4 weeks prior to inclusion. * Having suffered a Cerebrovascular Accident (CVA) or a Transient Ischemic Accident (TIA) in the 3 months prior to inclusion. * NYHA Class IV. * Having received a heart transplant or being waiting to receive it (status I classification); * Suffering from primary valve disease requiring surgical intervention. * Having long-lasting or permanent atrial fibrillation * Showing inadequate transthoracic echocardiographic images which will not allow to establish cardiac output and LV volumes. * Having a life expectancy \<12months. * Being pregnant or planning to become pregnant during the clinical investigation. * Inability to meet the monitoring schedule. * Currently participating in any other clinical interventional research. * Having a permanent high degree AV block