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

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ClinicalTrials.gov Identifier: NCT03961399
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.


Condition or disease Intervention/treatment Phase
Heart Failure Device: Abbott Medical® CRT device with SyncAVTM stimulation function Device: Abbott Medical® CRT device with biventricular stimulation (BiV) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postmarketing, Prospective, Multicenter, Randomized and Blinded Study to Evaluate the Superior Efficacy of Cardiac Resynchronization Using the SyncAVTM Algorithm
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: biventricular stimulation (BiV) group
patients with Abbott Medical® CRT implanted with only biventricular stimulation (BiV).
Device: Abbott Medical® CRT device with biventricular stimulation (BiV)
patients with Abbott Medical® CRT device will be randomized and biventricular (BiV) stimulation will be activated.

Experimental: SyncAVTM stimulation group
patients with Abbott Medical® CRT implanted and SyncAVTM stimulation activated
Device: Abbott Medical® CRT device with SyncAVTM stimulation function
patients with Abbott Medical® CRT device will be randomized and SyncAVTM stimulation will be activated.




Primary Outcome Measures :
  1. Number of responders patients evaluating the superiority of CRT with ventricular stimulation with fusion using the SyncAV TM algorithm versus BiV conventional stimulation [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Inverse remodeling of the LV [ Time Frame: 6 months ]

    It will be measured as the changes into the left ventricle end systolic volume (LVESV) and left ventricle end diastolic volume(LVEDV) in comparison with the Basal situation without stimulation.

    Changes of LV will be measured by echocardiogram in the apical 4-chamber plane using General Electric equipment (VIVID E9) and reviewing images obtained by VIVID E9 program following the GUIDELINES AND STANDARDS "Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging".


  2. Inverse remodeling of the LV [ Time Frame: 6 months ]

    It will be measured as the changes into the Left Ventricle end diastolic diameter (LVEDD) in comparison with the Basal situation without stimulation.

    Changes of LV will be measured by echocardiogram in the apical 4-chamber plane using General Electric equipment (VIVID E9) and reviewing images obtained by VIVID E9 program following the GUIDELINES AND STANDARDS "Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging".


  3. Inverse remodeling of the LV [ Time Frame: 6 months ]

    It will be measured as the changes into the Left Ventricular Ejection Fraction (LVEF) in comparison with the Basal situation without stimulation.

    Changes of LV will be measured by echocardiogram in the apical 4-chamber plane using General Electric equipment (VIVID E9) and reviewing images obtained by VIVID E9 program following the GUIDELINES AND STANDARDS "Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging"


  4. Quality of life variable according to KCCQ-12 survey [ Time Frame: 6 months ]
    It comprises 23 items in seven domains: physical limitation; symptoms, with domains for change over time, frequency, and severity; self-efficacy and knowledge; quality of life; and social interference. The response options for the items are Likert-type scales ranging from 1 to 5, 6 or 7 points and the score on each domain can, in theory, range from 0 to 100, with 100 corresponding to the best state

  5. Number of appropriate / inappropriate discharge in patients [ Time Frame: 6 months ]
    Throughout the visits dates and/or hospital incoming.

  6. % of patients with AF and AF load [ Time Frame: 6 months ]
    These % of Atrial fibrilation will be evaluated by each MD at the site face-to-face with the patients.

  7. % of patients who lose the possibility of SyncAV TM (BAV, lengthening of interval (PR) ...) [ Time Frame: 6 months ]
    Throughout the visits dates and/or hospital incoming.

  8. Comparison of the echocardiographic parameters with the cohort of patients stratified according to the etiology (ischemic patients versus to non-ischemic patients) [ Time Frame: 6 months ]
    Comparison of the echocardiographic parameters with the cohort of patients stratified according to the etiology (ischemic patients versus to non-ischemic patients)

  9. NYHA Class Change [ Time Frame: 6 months ]
    By evaluating it at the on-site visit from each patients

  10. Mortality from any cause [ Time Frame: 6 months ]
    Mortality from any cause

  11. Hospitalization rate for any cause, due to cardiovascular causes and / or heart failure [ Time Frame: 6 months ]
    Hospitalization rate for any cause, due to cardiovascular causes and / or heart failure

  12. Combined mortality and hospitalization variable for heart failure [ Time Frame: 6 months ]
    Combined mortality and hospitalization variable for heart failure

  13. % FA (no patients / FA load) [ Time Frame: 6 months ]
    % FA (no patients / FA load)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Having suffered myocardial infarction or unstable angina in the 40 days prior to inclusion.
  • NYHA Class IV.
  • 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.
  • 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.
  • 2nd or 3rd grade of AV block.
  • PR> 250 ms.
  • Atrial Fibrillation (AF): Persistent AF at the time of inclusion or 30 days before, or permanent FA not treated with ablation of the AV node in the 2 weeks following the implantation of the CRT, or History or incidence of Paroxysmal or Persistent FA in the 30 days prior to inclusion.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961399


Contacts
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Contact: Jaume Francisco Pascual, MD +34932746166 jfranciscopascual@gmail.com

Locations
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Spain
Hospital Universitari Germans Trias i Pujol Not yet recruiting
Badalona, Barcelona, Spain, 08916
Contact: Roger Villuendas, Dr.       rogervilluendas@hotmail.com   
Hospital Universitari de Bellvitge Not yet recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Ignasi Anguera, Dr.       ignasi.anguera@gmail.com   
Hospital Universitario Marqués de Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Contact: Víctor Espósito, Dr.       vicast79@hotmail.com   
Hospital Insular de las Palmas Not yet recruiting
Las Palmas De Gran Canaria, Las Palmas, Spain, 35016
Contact: Olga Medina, Dra.         
Contact       Omedina@telefonica.net   
Hospital Universitario Cruces Not yet recruiting
Baracaldo, Vizcaya, Spain, 48903
Contact: Iñigo Sainz Godoy, Dr.       inigo.sainzgodoy@osakidetza.eus   
Hospital Universitario Puerta del Mar Not yet recruiting
Cadiz, Vizcaya, Spain, 11009
Contact: Juan Fernández Armenta, Dr.       juanfdezarmenta@gmail.com   
Hospital Universitario de Galdakao Not yet recruiting
Galdakao, Vizcaya, Spain, 48960
Contact: Germán Zugazabeitia, Dr.       GERMAN.ZUGAZABEITIAIRAZABAL@osakidetza.eus   
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Jaume Francisco Pascual, Dr       jfranciscopascual@gmail.com   
Contact    +34932746166      
Hospital Universitario de Girona Dr. Josep Trueta Not yet recruiting
Girona, Spain, 17007
Contact: Emilce Trucco, Dra.       metrucco.girona.ics@gencat.cat   
Hospital Fundación Jimenez Díaz Not yet recruiting
Madrid, Spain, 28040
Contact: José Manuel Rubio, Dr.       jmrubio@fjd.es   
Hospital Álvaro Cunqueriro Not yet recruiting
Pontevedra, Spain, 36312
Contact: Pilar Cabanas Grandío, Dra.       Pilicgrandio@yahoo.es   
Hospital Virgen de la Salud Not yet recruiting
Toledo, Spain, 45071
Contact: Miguel Ángel Arias, Dr.       maapalomares@secardiologia.es   
Hospital General Universitario de Valencia Not yet recruiting
Valencia, Spain, 46014
Contact: Aurelio Quesada, Dr.       quesada_aur@gva.es   
Hospital Universitario Dr. Peset Not yet recruiting
Valencia, Spain, 46017
Contact: José Ferrando, Dr.       ferrandocervello@comv.es   
Hospital Universitario de Valladolid Not yet recruiting
Valladolid, Spain, 47003
Contact: Jerónimo Rubio Sanz, Dr.       jrubio@vitanet.nu   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Jaume Francisco Pascual, MD Institut of research Vall d'hebron Hospital (VHIR)

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03961399     History of Changes
Other Study ID Numbers: CRUSTY
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No participant data will be shared to other researchers.

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

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases