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Trial record 1 of 1 for:    BUDAPEST-CRT Upgrade
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Budapest Upgrade CRT Study (Version 009-4.1)

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ClinicalTrials.gov Identifier: NCT02270840
Recruitment Status : Unknown
Verified November 2017 by Semmelweis University Heart and Vascular Center.
Recruitment status was:  Enrolling by invitation
First Posted : October 21, 2014
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
University of Rochester
Sheba Medical Center
Pharmahungary Group
Information provided by (Responsible Party):
Semmelweis University Heart and Vascular Center

Brief Summary:
Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes in patient in left ventricular dysfunction and intermittent or permanent apical/septal right ventricular pacing (Budapest CRT upgrade study)

Condition or disease Intervention/treatment
Cardiomyopathy Device: CRT-D

Detailed Description:

The aim of this study is to investigate the effect of upgrade to a CRT-D device on clinical and echocardiographic response at 12-month in patients with left ventricular dysfunction (LVEF ≤35%), symptomatic heart failure (NYHA II, III, IV-a), and intermittent or permanent right ventricular pacing with paced QRS complex ≥ 150 ms compared to continued therapy with a single or dual chamber pacemaker (PM) or ICD.

Prospective, post-market, international multicenter randomized controlled trial.

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Biventricular Upgrade on Left Ventricular Reverse Remodeling and Clinical Outcomes in Patient With Left Ventricular Dysfunction and Intermittent or Permanent Apical/Septal Right Ventricular Pacing (Budapest CRT Upgrade Study)
Study Start Date : November 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Group/Cohort Intervention/treatment
CRT-D
Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT.
Device: CRT-D
Biventricular upgrade. Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).

Only ICD

In the ICD arm, choosing single or dual chamber device is based upon the investigator's discretion.

Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).




Primary Outcome Measures :
  1. A composite clinical and echocardiographic end point comprising the first occurrence of a non-fatal heart failure event, all-cause mortality, or < 15% reduction in echocardiography determined LVESV from baseline to 12-month. [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Altogether 360 subjects will be enrolled at the European and Israeli study sites, randomized in the rate of 3:2 (CRT-D:ICD groups).
Criteria

Inclusion Criteria:

  • Male or female patients over the age of 18 (expected survival time: over 1 year)
  • Patients with ischemic or non-ischemic cardiomyopathy;
  • Those implanted with a single or dual chamber ICD or implanted with a single or dual chamber pacemaker at least 6 months before inclusion;
  • Elective generator replacement or upgrade from pacemaker-only to ICD therapy may be indicated at the time of enrollment, but are not required;
  • Right ventricular pacing 20-100% in at least the last 90 days before enrollment (with an optimal AV interval based on the physician's discretion to avoid unnecessary right ventricular stimulation);
  • Symptomatic heart failure for at least 3 months before inclusion;
  • NYHA functional class II or III, or IV a;
  • Left ventricular ejection fraction measured by echocardiography ≤ 35%;
  • Paced QRS complex ≥ 150 ms;
  • Optimal heart failure medical therapy;
  • Informed consent obtained.

Exclusion Criteria:

  • Intrinsic QRS with LBBB morphology (measured at VVI 40 bpm setting as per protocol);
  • CABG or PCI in the past 3 months;
  • Acute myocardial infarction in the past 3 months;
  • Unstable angina;
  • Planned coronary revascularization (PCI or CABG);
  • Planned cardiac transplantation;
  • Acute myocarditis;
  • Infiltrative myocardial disease;
  • Hypertrophic cardiomyopathy;
  • Severe primary mitral and aortic valve stenosis or regurgitation;
  • Women who are pregnant or plan to become pregnant or breastfeeding;
  • Subjects who are unable or unwilling to cooperate with the study protocol;
  • Tricuspid valve prosthesis;
  • Any serious disease likely to interfere with the conduct of the study;
  • Participation in other clinical trial;
  • Patients geographically not stable or unavailable for follow-up;
  • Chronic, severe renal dysfunction (creatinine value > 200 μmol/l);
  • Severe RV dilatation (RV basal diameter >50mm);
  • Severe tricuspid insufficiency.

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): NCT02270840


Locations
Show Show 23 study locations
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center
University of Rochester
Sheba Medical Center
Pharmahungary Group
Investigators
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Study Director: Valentina Kutyifa, MD University of Rochester Medical Center, Rochester, NY, USA
Study Director: Ilan Goldenberg, Prof. MD Sheba Medical Center Tel-Hashomer, Israel
Principal Investigator: Béla Merkely, Prof. MD Semmelweis University Hearth and Vascular Center, Budapest, Hungary
Study Director: Annamaria Kosztin, MD Semmelweis University Hearth and Vascular Center, Budapest, Hungary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier: NCT02270840    
Other Study ID Numbers: Budapest Upgrade CRT 009-4.1
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Keywords provided by Semmelweis University Heart and Vascular Center:
cardiac resynchronization therapy
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases