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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 +)

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SyncAV function on
Sponsored by
Antonio Rapacciuolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SyncAV plus group

    Biv Trad

    Arm Description

    Patients implanted with a CRT-D programmed with SyncAV plus function ON.

    Patients implanted with a CRT-D programmed with fixed AV delay.

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    September 13, 2023
    Sponsor
    Antonio Rapacciuolo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06044597
    Brief 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).
    Acronym
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2026 (Anticipated)
    Study Completion Date
    October 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Antonio Rapacciuolo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    Detailed Description
    Treatment of HFrEF with CRT. CRT is an established guideline-recommended treatment for patients who are refractory to optimized pharmacologic therapy, and have reduced ejection fraction and increased QRS duration. It works by restoring atrioventricular, inter- and intra-ventricular synchrony and in so doing, it has been shown to improve symptoms, LV systolic function and survival. Nevertheless, a significant proportion of patients (30-45%) do not benefit after CRT and are considered non-respondent. Non-response to CRT is multifactorial (poor substrate to resynchronize, difficulty in the implant, age, gender, aetiology, and/or comorbidities). Recently, other negative determinants have been identified as cause of non-responding to CRT such as the lack of fusion of ventricular contraction with the intrinsic right ventricular conduction and non-optimal AV delay programming which, in turn, is related to the duration of PR interval. Another possible reason for non-responding to CRT is a non-optimal LV pacing site. The CRUSTY PLUS trial is aimed to establish the relevance for the success of CRT of these three factors: lack of fusion, non-optimized A-V conduction, and LV pacing site by comparing the response to CRT with a standard BIV device with fixed out-of-the-box A-V delay with that to a BIV device (Sync A-V plus) endowed with an algorithm which is continuously measuring the patients' A-V conduction and is able to adjust the stimulation parameters according to the measured PR interval, achieving a more dynamic A-V interval and allowing a perfect fusion of ventricular contraction. The algorithm is also able to optimize LV intraventricular synchrony. Sync A-V plus is endowed with a quadripolar multipoint pacing (MPP) CRT-D system allowing pacing of the LV with 2 vectors. This methodology allows a simultaneous earlier and wider excitation of ventricular tissue resulting in better synchronization and better cardiac output.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized study with 2 groups: control group (Traditional biventricular stimulation), study group (biventricular stimulation + SyncAV feature)
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    722 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SyncAV plus group
    Arm Type
    Experimental
    Arm Description
    Patients implanted with a CRT-D programmed with SyncAV plus function ON.
    Arm Title
    Biv Trad
    Arm Type
    No Intervention
    Arm Description
    Patients implanted with a CRT-D programmed with fixed AV delay.
    Intervention Type
    Device
    Intervention Name(s)
    SyncAV function on
    Intervention Description
    CRT-D with SyncAV plus activated
    Primary Outcome Measure Information:
    Title
    Reduction in left ventricular end systolic volume (LVESV) between baseline and 6 months
    Description
    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
    Time Frame
    Month 6
    Title
    Reduction in QRS duration after randomization
    Description
    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.
    Time Frame
    within 10 days
    Secondary Outcome Measure Information:
    Title
    Percentage of CRT Responders at 12 months after MPP activation programmed after the 6 Months follow-up.
    Description
    Percentage of non-responders at 6 Months responders at 12 Months with MPP
    Time Frame
    Month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonio Rapacciuolo, Prof
    Phone
    0817462235
    Email
    antonio.rapacciuolo@unina.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaume Francisco Pascual, Dr
    Organizational Affiliation
    Hospital Vall d'Hebron
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Nuria Rivas Gandara, Dr
    Organizational Affiliation
    Hospital Vall d'Hebron
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Angelo Auricchio, Prof
    Organizational Affiliation
    Istituto Cardiocentro Ticino
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    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).

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