CRT Improved Clinical Response UK Trial (CRICKET)
Primary Purpose
Cardiac Failure
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Device programming
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Failure focused on measuring cardiac resynchronization therapy, optimization, heart failure, reverse left ventricular remodeling
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
SonR optimization
Fixed settings
Arm Description
SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming: SonR CRT Optimization programmed "AV+VV"
SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming device programming: sensed AV delay of 125 ms, VV delay of 0 ms (simultaneous); SonR CRT Optimization programmed "Off").
Outcomes
Primary Outcome Measures
Left ventricular end-systolic volume (LVSV)
Reduction in LVESV with SonR vs FS after 6 months of treatment
Secondary Outcome Measures
Walking distance on 6 -minute walk test
Change in 6 MWT distance
NYHA class
Change in NYHA class
Quality of life - general (non-disease specific)
Change in quality of life, assessed using EQ-5D (section 1)
Patient global assessment
Change in patient global assessment (included in EQ-5D, section 2)
Disease-specific quality of life (heart failure)
Change in quality of life (MLWHF questionnaire)
Left ventricular ejection fraction
Change in LVEF
AF burden
AF burden according to mode-switches
System safety assessed by Adverse Events
Report all Adverse Events
Full Information
NCT ID
NCT02669134
First Posted
December 17, 2015
Last Updated
August 1, 2023
Sponsor
Aston University
Collaborators
University Hospital Birmingham NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02669134
Brief Title
CRT Improved Clinical Response UK Trial
Acronym
CRICKET
Official Title
CRT Improved Clinical Response UK Trial: A Multi-centre, Prospective, Randomized, Cross-over, Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
no record of study starting
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aston University
Collaborators
University Hospital Birmingham NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This is an investigator-initiated, multi-centre, 2:2 factorial design, randomized, two-arm, double-blinded, cross-over, prospective trial
Main study objectives
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.
Study endpoints
Primary endpoint: The primary endpoint is a reduction (absolute difference) in LVESV with SonR vs FS after 6 months of treatment. The difference intra-patient of absolute change of LVESV value will be compared between two treatments: "SonR optimization" vs. "FS", defined as a sensed AV delay of 125 ms, VV delay of 0 ms (simultaneous).
Secondary endpoints:
Change in 6 MWT distance Change in NYHA class Change in quality of life Change in patient global assessment (EQ-5D) Change in Quality of life (MLWHF questionnaire) Change in LVEF AF burden Adverse Events
Number of subjects
Two hundred (200) patients will be enrolled. All patients will be implanted with the SonRtip bipolar atrial lead and a LivaNova (Sorin) CRT-D device offering both SonR optimization algorithm and atrio-biventricular pacing. Patients will be assigned to either the treatment or control arms, employing a 1:1 randomization with up to 100 patients in each of the 2 groups: Study Group (SonR CRT Optimization programmed "AV+VV") and Control Group ("Fixed Settings" (FS), defined as a sensed AV delay of 125 ms, VV delay of 0 ms (simultaneous); SonR CRT Optimization programmed "Off"). After the first 6 months, patients will be crossed-over to the alternative arm for another 6 months. There will be no washout period.
Duration of the clinical investigation
The study inclusion phase is expected to last approximately 1.5 years.
Follow-ups
Patients will be evaluated at baseline and randomized prior to implantation to SonR optimization or FS. A further clinical assessment, ECG and echocardiography will be undertaken at 6 months. At this point, patients will be crossed over to the other arm for another 6 months. The study closes following a further clinical and echocardiographic assessment at 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure
Keywords
cardiac resynchronization therapy, optimization, heart failure, reverse left ventricular remodeling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SonR optimization
Arm Type
Active Comparator
Arm Description
SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming: SonR CRT Optimization programmed "AV+VV"
Arm Title
Fixed settings
Arm Type
Placebo Comparator
Arm Description
SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming device programming: sensed AV delay of 125 ms, VV delay of 0 ms (simultaneous); SonR CRT Optimization programmed "Off").
Intervention Type
Other
Intervention Name(s)
Device programming
Intervention Description
SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming: SonR CRT Optimization programmed "AV+VV"
Primary Outcome Measure Information:
Title
Left ventricular end-systolic volume (LVSV)
Description
Reduction in LVESV with SonR vs FS after 6 months of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Walking distance on 6 -minute walk test
Description
Change in 6 MWT distance
Time Frame
6 months
Title
NYHA class
Description
Change in NYHA class
Time Frame
6 months
Title
Quality of life - general (non-disease specific)
Description
Change in quality of life, assessed using EQ-5D (section 1)
Time Frame
6 months
Title
Patient global assessment
Description
Change in patient global assessment (included in EQ-5D, section 2)
Time Frame
6 months
Title
Disease-specific quality of life (heart failure)
Description
Change in quality of life (MLWHF questionnaire)
Time Frame
6 months
Title
Left ventricular ejection fraction
Description
Change in LVEF
Time Frame
6 months
Title
AF burden
Description
AF burden according to mode-switches
Time Frame
6 months
Title
System safety assessed by Adverse Events
Description
Report all Adverse Events
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nichola Seare, PhD
Organizational Affiliation
Aston University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
CRT Improved Clinical Response UK Trial
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