Study to Evaluate the Superior Efficacy of Cardiac Resynchronization (SyncAVTM) Using the SyncAVTM Algorithm

NCT03961399 | Completed

• 1 other identifier: CRUSTY
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 15

Brief Summary

Heart Failure (HF) is a cardiovascular disease secondary to a structural and / or functional alteration of the heart that prevents its correct function. The Cardiac resynchronization therapy (CRT) aims to restore atrioventricular, inter and intraventricular synchrony in patients with systolic HF and wide depolarization of the ventricles (QRS). Although CRT has been shown to be effective, the rate of non-responders is high (30-50%). One of the proposed reasons for the lack of response to the CRT is the lack of intrinsic conduction, since most of the time CRT is administered using biventricular stimulation (BiV). One of the limitations to achieve ventricular fusion are the dynamic physiological variations of the auriculo-ventricular (AV) interval. The SyncAVTM algorithm is a new dynamic algorithm that manages to adjust the AV intervals outside the clinic. The design of the present clinical study is post-marketing, prospective, multicenter, randomized and blind for the patient and the central echocardiography laboratory. The objective of this study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with conventional BiV stimulation in the population for which its use is foreseen. The data will be collected in at least the Selection / Baseline Visit and in the Visit of Follow-up at 6 Months. The study population are subjects to whom an Abbott Medical CRT has been implanted with SyncAVTM® Stimulation function that go to the participating sites in the study. The main objective of the study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with BiV stimulation conventional in terms of the rate of responders. The main endpoint is the determination of significant differences between conventional BiV stimulation and ventricular stimulation with fusion using the SyncAVTM algorithm in terms of the percentage of patients responding to CRT therapy with echocardiogram. The duration of the clinical study is estimated at 24 months with a recruitment period of 18 months and a patient follow-up of 6 months. The number of subjects that is planned to be recruited is 176. The inclusion will be competitive and there is no inclusion number determined per site.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of responders patients evaluating the superiority of CRT with ventricular stimulation with fusion using the SyncAV TM algorithm versus BiV conventional stimulation

  The assessment of the main objective must be carried out on a population that has been implanted an Abbott Medical® CRT with SyncAV TM Stimulation function under the current ESC Class I or Class II-a indications for CRT implantation (including pacemaker or single-chamber or dual chamber of an implantable cardioverter defibrillator (DAI) updates

  6 months

Secondary Outcomes (13)

• Inverse remodeling of the LV

  6 months

• Inverse remodeling of the LV

  6 months

• Inverse remodeling of the LV

  6 months

• Quality of life variable according to KCCQ-12 survey

  6 months

• Number of appropriate / inappropriate discharge in patients

  6 months

Study Arms (2)

biventricular stimulation (BiV) group

ACTIVE COMPARATOR

patients with Abbott Medical® CRT implanted with only biventricular stimulation (BiV).

Device: Abbott Medical® CRT device with biventricular stimulation (BiV)

SyncAVTM stimulation group

EXPERIMENTAL

patients with Abbott Medical® CRT implanted and SyncAVTM stimulation activated

Device: Abbott Medical® CRT device with SyncAVTM stimulation function

Interventions

Abbott Medical® CRT device with SyncAVTM stimulation function DEVICE

patients with Abbott Medical® CRT device will be randomized and SyncAVTM stimulation will be activated.

SyncAVTM stimulation group

Abbott Medical® CRT device with biventricular stimulation (BiV) DEVICE

patients with Abbott Medical® CRT device will be randomized and biventricular (BiV) stimulation will be activated.

biventricular stimulation (BiV) group

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years.
• Patients who state that they understand the study and are willing to participate in it by signing the corresponding Informed Consent form.
• Patients who have been implanted with an Abbott Medical ® CRT with SyncAVTM stimulation function under the current ESC Class I or Class II-a indications for the implantation of CRT (including updates from pacemakers or single-chamber or double-chamber of an implantable cardioverter-defibrillator (ICDs)).
• In sinus rhythm during the Basal visit.
• Patients with Left Branch Block (LBB) defined as:
• QRS duration\> 120 msec
• interval (QS) or interval (rS) in V1
• Single phase R (without Q wave) in V6 and interval (DI)
• LVEF \<35% being under optimal medical treatment
• PR Baseline \<250 ms without BAV of 2nd or 3rd grade.
• Patients who are willing to meet all the requirements of the study and who have the ability to do it.

You may not qualify if:

• NYHA Class IV.
• Have a status of 1 for heart transplantation or be evaluated to receive a transplant in the next 12 months.
• Primary valve disease that requires surgical intervention.
• nd or 3rd grade of AV block.
• PR\> 250 ms.
• Patient in whom adequate transthoracic echocardiographic images can not be obtained to establish cardiac output and VI volumes.
• Have received a heart transplant or are waiting to receive it.
• Have a life expectancy \<6 months.
• Being pregnant or intending to become pregnant during the study.
• Inability to comply with the follow-up calendar.
• Being currently participating in any other clinical study

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (15)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Insular de las Palmas

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Vizcaya, 11009, Spain

Location

Hospital Universitario de Galdakao

Galdakao, Vizcaya, 48960, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital Fundación Jimenez Díaz

Madrid, 28040, Spain

Location

Hospital Álvaro Cunqueriro

Pontevedra, 36312, Spain

Location

Hospital Virgen de la Salud

Toledo, 45071, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Hospital Universitario de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jaume Francisco Pascual, MD

  Institut of research Vall d'hebron Hospital (VHIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: May 23, 2019
• Study Start: December 18, 2018
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)