cardiomyopathy congestive heart failure
Conditions
Interventions
Implantation of LBB electrode.
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Age 18+ -Ischemic or non-ischemic cardiomyopathy with LVEF 90% right ventricular pacing from an existing pacemaker
Exclusion criteria
Exclusion criteria: - Existing biventricular pacing system - Permanent atrial fibrillation - AMI or CABG within the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate for implantation of LBB electrode. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints (LBB pacing versus biventricular pacing - calculated both as intention-to-treat and per-protocol): - Echocardiographic response after 6 months defined as decrease in left ventricular systolic diameter of >= 15% of baseline - Echocardiographic response assessed by chamber dimensions and LVEF on a continuous scale - Symptomatic response after 6 months defined as a fall in NYHA class of >= 1 - Improvement in well-being after 6 months defined as a decrease in Minnesota Living With Heart Failure score of >= 15% of baseline. - Shortening the duration of the QRS complex defined as the widest paced QRS complex rated at 12-lead ECG after 6 months. - Decline in NT-pro BNP value. - Device-related complications: *Periprocedural: CS/LBB electrode reoperation, pneumothorax, hemothorax, pericardial bleeding/tamponade. *One month postoperative: CS/LBB electrode reoperation, phrenic nerve stimulation, infection requiring extraction. | — |
Countries
Netherlands
Outcome results
None listed