SONR-ECHO: Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

SONR-ECHO: Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography - SONR-ECHO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40954

Enrollment

Registered

2014-09-11

Start date

2015-06-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure heart rhythm disorder

Interventions

All patients will undergo, at enrolment and after 6 months, an echocardiographic evaluation of the heart.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - indication for a CRT-D implant - in sinus rhythm - signed informed consent

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Left ventricular end-systolic volume Left ventricular filling time	—

Secondary

Measure	Time frame
A-wave truncation Left ventricular end-diastolic volume Left ventricular ejection fraction Incidence of atrial fibrillation Adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)