Cardiac Failure Clinical Trial
— CRICKETOfficial title:
CRT Improved Clinical Response UK Trial: A Multi-centre, Prospective, Randomized, Cross-over, Double Blind Study
Verified date | August 2023 |
Source | Aston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6 months of treatment. In this investigator-initiated, multi-centre, 2:2 factorial design, randomized, two-arm, double-blinded, cross-over, prospective trial, CRT recipients will be randomized to 'SonR' atrioventricular (AV) and ventricular-ventricular (VV) optimization or 'fixed settings'. The primary endpoint is an absolute reduction in left ventricular end-systolic volume.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Eligible for implantation of a CRT-D device according to current NICE or ESC guidelines; - In sinus rhythm; - NYHA class II, III or IV - Have reviewed, signed and dated an informed consent Exclusion Criteria: - Inability to do a 6 min walk test. - Previous implant with a pacemaker, an ICD or a CRT device (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance); - Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month; - Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; - Incessant ventricular tachyarrhythmia; - Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks; - Correctable valvular disease that is the primary cause of heart failure; - Indication for valve repair or replacement; - Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months); - On transplant waiting list; - Previous heart transplant; - Already included in another clinical study that could confound the results of this study; - Life expectancy less than 1 year; - Inability to understand the purpose of the study; - Unavailability for scheduled follow-up or refusal to cooperate; - Age of less than 18 years; - Pregnancy; - Drug addiction or abuse; - Under guardianship. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aston University | University Hospital Birmingham NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular end-systolic volume (LVSV) | Reduction in LVESV with SonR vs FS after 6 months of treatment | 6 months | |
Secondary | Walking distance on 6 -minute walk test | Change in 6 MWT distance | 6 months | |
Secondary | NYHA class | Change in NYHA class | 6 months | |
Secondary | Quality of life - general (non-disease specific) | Change in quality of life, assessed using EQ-5D (section 1) | 6 months | |
Secondary | Patient global assessment | Change in patient global assessment (included in EQ-5D, section 2) | 6 months | |
Secondary | Disease-specific quality of life (heart failure) | Change in quality of life (MLWHF questionnaire) | 6 months | |
Secondary | Left ventricular ejection fraction | Change in LVEF | 6 months | |
Secondary | AF burden | AF burden according to mode-switches | 6 months | |
Secondary | System safety assessed by Adverse Events | Report all Adverse Events | 6 months |
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