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
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Estimated Enrollment :||360 participants|
|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|
Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT.
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).
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).
- 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 ]
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
|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|