NCT02669134

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 2, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

December 17, 2015

Last Update Submit

August 1, 2023

Conditions

Cardiac Failure

Keywords

cardiac resynchronization therapyoptimizationheart failurereverse left ventricular remodeling

Outcome Measures

Primary Outcomes (1)

  • Left ventricular end-systolic volume (LVSV)

    Reduction in LVESV with SonR vs FS after 6 months of treatment

    6 months

Secondary Outcomes (8)

  • Walking distance on 6 -minute walk test

    6 months

  • NYHA class

    6 months

  • Quality of life - general (non-disease specific)

    6 months

  • Patient global assessment

    6 months

  • Disease-specific quality of life (heart failure)

    6 months

  • +3 more secondary outcomes

Study Arms (2)

SonR optimization

ACTIVE COMPARATOR

SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming: SonR CRT Optimization programmed "AV+VV"

Other: Device programming

Fixed settings

PLACEBO COMPARATOR

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").

Other: Device programming

Interventions

Device programmingOTHER

SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming: SonR CRT Optimization programmed "AV+VV"

Fixed settingsSonR optimization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Nichola Seare, PhD

    Aston University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

January 29, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 2, 2023

Record last verified: 2023-08