Heart Failure Clinical Trial
— CRUSTYOfficial title:
Postmarketing, Prospective, Multicenter, Randomized and Blinded Study to Evaluate the Superior Efficacy of Cardiac Resynchronization Using the SyncAVTM Algorithm
Verified date | October 2023 |
Source | Hospital Universitari Vall d'Hebron Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | October 27, 2021 |
Est. primary completion date | October 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
Spain | Hospital Universitario Cruces | Baracaldo | Vizcaya |
Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
Spain | Hospital Universitario Puerta del Mar | Cadiz | Vizcaya |
Spain | Hospital Universitario de Galdakao | Galdakao | Vizcaya |
Spain | Hospital Universitario de Girona Dr. Josep Trueta | Girona | |
Spain | Hospital Universitari de Bellvitge | Hospitalet de Llobregat | Barcelona |
Spain | Hospital Insular de las Palmas | Las Palmas De Gran Canaria | Las Palmas |
Spain | Hospital Fundación Jimenez Díaz | Madrid | |
Spain | Hospital Álvaro Cunqueriro | Pontevedra | |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria |
Spain | Hospital Virgen de la Salud | Toledo | |
Spain | Hospital General Universitario de Valencia | Valencia | |
Spain | Hospital Universitario Dr. Peset | Valencia | |
Spain | Hospital Universitario de Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Inverse remodeling of the LV | 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". |
6 months | |
Secondary | Inverse remodeling of the LV | 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". |
6 months | |
Secondary | Inverse remodeling of the LV | 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" |
6 months | |
Secondary | Quality of life variable according to KCCQ-12 survey | 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 | 6 months | |
Secondary | Number of appropriate / inappropriate discharge in patients | Throughout the visits dates and/or hospital incoming. | 6 months | |
Secondary | % of patients with AF and AF load | These % of Atrial fibrilation will be evaluated by each MD at the site face-to-face with the patients. | 6 months | |
Secondary | % of patients who lose the possibility of SyncAV TM (BAV, lengthening of interval (PR) ...) | Throughout the visits dates and/or hospital incoming. | 6 months | |
Secondary | Comparison of the echocardiographic parameters with the cohort of patients stratified according to the etiology (ischemic patients versus to non-ischemic patients) | Comparison of the echocardiographic parameters with the cohort of patients stratified according to the etiology (ischemic patients versus to non-ischemic patients) | 6 months | |
Secondary | NYHA Class Change | By evaluating it at the on-site visit from each patients | 6 months | |
Secondary | Mortality from any cause | Mortality from any cause | 6 months | |
Secondary | Hospitalization rate for any cause, due to cardiovascular causes and / or heart failure | Hospitalization rate for any cause, due to cardiovascular causes and / or heart failure | 6 months | |
Secondary | Combined mortality and hospitalization variable for heart failure | Combined mortality and hospitalization variable for heart failure | 6 months | |
Secondary | % FA (no patients / FA load) | % FA (no patients / FA load) | 6 months |
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