Heart Failure Clinical Trial
— CRUSTY +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)
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.
Status | Not yet recruiting |
Enrollment | 722 |
Est. completion date | October 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Antonio Rapacciuolo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in left ventricular end systolic volume (LVESV) between baseline and 6 months | The primary endpoint is response to CRT defined as > 15% relative reduction in Left Ventricular End Systolic Volume (LVESV) at 6 months after implantation, evaluated by Echocardiography | Month 6 | |
Primary | Reduction in QRS duration after randomization | The primary endpoint is the reduction of QRS duration compared to the intrinsic QRS. Defined as > 13% relative reduction in QRS duration compared with the intrinsic QRS, evaluated by ECG.Defined as > 13% relative reduction in QRS duration compared with the intrinsic QRS, evaluated by ECG. |
within 10 days | |
Secondary | Percentage of CRT Responders at 12 months after MPP activation programmed after the 6 Months follow-up. | Percentage of non-responders at 6 Months responders at 12 Months with MPP | Month 6 |
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