Heart FailureCRUSTY +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).
A study testing SyncAV function on in people with Heart Failure, run by Antonio Rapacciuolo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SyncAV function on
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- SyncAV function on
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyncAV function onDevice
CRT-D with SyncAV plus activated
| Study group | Role | What they receive |
|---|---|---|
| SyncAV plus group | Experimental | Patients implanted with a CRT-D programmed with SyncAV plus function ON. Receives: Device: SyncAV function on |
| Biv Trad | No intervention | Patients implanted with a CRT-D programmed with fixed AV delay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 6
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.
Measured: within 10 days
Secondary outcomes (1)
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
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study with 2 groups: control group (Traditional biventricular stimulation), study group (biventricular stimulation + SyncAV feature)
- Masking
- None (open label)
- Enrolment
- 722 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Rapacciuolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Rapacciuolo, Federico II University
- Investigators
- Jaume Francisco Pascual, Dr, Study chair, Hospital Vall d'HebronNuria Rivas Gandara, Dr, Study chair, Hospital Vall d'HebronAngelo Auricchio, Prof, Study chair, Istituto Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044597
- Sponsor's protocol ID
- DE-66-22
- Acronym
- CRUSTY +
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06044597
- Acronym / sponsor ID
- CRUSTY + / DE-66-22
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 722 participants (estimated)
- Lead sponsor
- Antonio RapacciuoloUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study with 2 groups: control group (Traditional biventricular stimulation), study group (biventricular stimulation + SyncAV feature)
| Arm | Type | Receives |
|---|---|---|
| SyncAV plus group | Experimental | Device: SyncAV function onPatients implanted with a CRT-D programmed with SyncAV plus function ON. |
| Biv Trad | No intervention | –Patients implanted with a CRT-D programmed with fixed AV delay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyncAV function onCRT-D with SyncAV plus activated | Device | SyncAV plus group |
Primary outcome
Reduction in left ventricular end systolic volume (LVESV) between baseline and 6 months
Time frame: Month 6
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
Time frame: within 10 days
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.
1 secondary outcome
Percentage of CRT Responders at 12 months after MPP activation programmed after the 6 Months follow-up.
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaume Francisco Pascual, Dr study chair
Hospital Vall d'Hebron
Nuria Rivas Gandara, Dr study chair
Hospital Vall d'Hebron
Angelo Auricchio, Prof study chair
Istituto Cardiocentro Ticino
Questions about this trial
What is this clinical trial studying?
A study testing SyncAV function on in people with Heart Failure, run by Antonio Rapacciuolo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Rapacciuolo, Prof (0817462235, antonio.rapacciuolo@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in left ventricular end systolic volume (LVESV) between baseline and 6 months (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.