Objective of the study is to demonstrate that CRT parameter optimisation using SonR technology can improve the responder rate, when using LV remodeling as a reference, compared to Standard of Care.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Left ventricular end-systolic volume
Left ventricular filling time
Secondary outcome
A-wave truncation
Left ventricular end-diastolic volume
Left ventricular ejection fraction
Incidence of atrial fibrillation
Adverse events
Background summary
Cardiac resynchronisation is an established therapy for patients with heart
failure presenting with a wide QRS and ventricular dyssynchrony. However, not
all patients are responders to the therapy. Since the introduction of CRT on a
large scale, it has been observed that approximately 30-40% of recipient
patients are non-responsive to the therapy. The number of non-responders can be
diminished by optimal device programming using SonR technology, especially wher
the AV and VV interval is concerned (CLEAR study). There are no data available
comparing LV remodeling in patients with SonR optimisation as opposed to
Standard of Care.
Study objective
Objective of the study is to demonstrate that CRT parameter optimisation using
SonR technology can improve the responder rate, when using LV remodeling as a
reference, compared to Standard of Care.
Study design
This is an international, multi-centre, 1:1 randomised, two-arm, double-blind
prospective study.
Intervention
All patients will undergo, at enrolment and after 6 months, an
echocardiographic evaluation of the heart.
Study burden and risks
No additional risk
Paasheuvelweg 1
Amsterdam 1100 AE
NL
Paasheuvelweg 1
Amsterdam 1100 AE
NL
Listed location countries
Age
Inclusion criteria
- indication for a CRT-D implant
- in sinus rhythm
- signed informed consent
Exclusion criteria
- previous implant of a resynchronisation device
- persistent atrial arrhythmias
- ventricular tachy-arrhythmias secondary to reversible causes
- incessant ventricular tachy-arrhythmias
- unstable angina, acute myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty in the last 4 weeks
- correctable valvular disease as a primary cause for heart failure
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49508.028.14 |