Budapest Upgrade CRT Study (Version 009-4.1)

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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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)

Conditions
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Cardiomyopathy

Intervention / Treatment
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* Device: CRT-D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRT-D<br>Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT. | Device: CRT-D<br>* 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).<br>|
| No Intervention: Only ICD<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac resynchronization therapy