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).

NCT06044597 | Not Yet Recruiting

• 1 other identifier: DE-66-22
• Study Type: interventional
• Target: 722
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Percentage of CRT Responders at 12 months after MPP activation programmed after the 6 Months follow-up.

  Month 6

Study Arms (2)

SyncAV plus group

EXPERIMENTAL

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

Device: SyncAV function on

Biv Trad

NO INTERVENTION

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

Interventions

SyncAV function on DEVICE

CRT-D with SyncAV plus activated

SyncAV plus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Antonio Rapacciuolo: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jaume Francisco Pascual, Dr

  Hospital Vall d'Hebron

  STUDY CHAIR

• Nuria Rivas Gandara, Dr

  Hospital Vall d'Hebron

  STUDY CHAIR

• Angelo Auricchio, Prof

  Istituto Cardiocentro Ticino

  STUDY CHAIR

Central Study Contacts

Antonio Rapacciuolo, Prof

CONTACT

0817462235; antonio.rapacciuolo@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized study with 2 groups: control group (Traditional biventricular stimulation), study group (biventricular stimulation + SyncAV feature)

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09