Status:
COMPLETED
Budapest Upgrade CRT Study (Version 009-4.1)
Lead Sponsor:
Semmelweis University Heart and Vascular Center
Collaborating Sponsors:
University of Rochester
Sheba Medical Center
Conditions:
Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 pa...
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%), sympto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02270840
Start Date
November 1 2014
End Date
August 1 2022
Last Update
June 6 2023
Active Locations (17)
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1
Hannover Medical School
Hanover, Germany, 30625
2
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
3
Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged
Szeged, Csongrád megye, Hungary, 6725
4
Institute of Cardiology University of Debrecen
Debrecen, Hajdú-Bihar, Hungary, 4032