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Cardiac Resynchronization Therapy in patients with systolic Heart Failure and mechanical dyssynchrony undergoing Coronary Artery Bypass Grafting

Cardiac Resynchronization Therapy in patients with systolic Heart Failure and mechanical dyssynchrony undergoing Coronary Artery Bypass Grafting - CABG-CRT

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38064
Enrollment
25
Registered
2011-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Heart Failure weakened heart muscle

Interventions

Patients are randomized into two groups: immediate treatment with CRT or standard medical therapy after CABG surgery. The patients in the "CABG + immediate CRT" group receive during or shortly after

Sponsors

Biotronik
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Planned CABG surgery systolic ischemic heart failure despite pharmacological therapy Left Ventricular Ejection Fraction 72 ms (to be confirmed by echo corelab)

Exclusion criteria

Exclusion criteria: Myocardial viability

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is to determine whether an improvement in cardiac function (remodeling of the heart and increase the ejection fraction) can be observed in patients with immediate aplication of CRT after CABG surgery.—

Secondary

MeasureTime frame
The secondary endpoints will examine the effect of this immediate treatment with CRT on the quality of life (using a QOL questionnaire), the exercise performance (using the 6 minutes walking test), heart failure symptoms (using the NYHA classification), the number of hospital admissions for heart failure and mortality.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)