Health Condition 1: I508- Other heart failure
Conditions
Interventions
Intervention1: Device Implantation: All participants will receive a dual chamber pacemaker. Patients will be randomized to either Bachmann Bundle Area or the Right Atrial Appendage atrial lead implant
Sponsors
Biotronic SE & Co KG (Biotronic)
Eligibility
Inclusion criteria
Inclusion criteria: -Symptomatic patients more than 18 years with Stage C HFpEF (LVEF greater than 50%) and chronotropic incompetence on optimized guideline indicated HF medical therapy -NYHA more than Class 2 and an elevated N-terminal pro-B type natriuretic peptide (NT-proBNP) level higher than 300 pg/ml -Partial or complete inter-atrial block (IAB) on ECG. -IAB will be defined as a maximum P wave duration greater than 120ms. Partial IAB will be defined as a P wave greater than 120ms with notching in leads II, III, or aVF. A P wave duration greater than 120ms and a biphasic morphology in leads II, III, aVF will be classified as advanced or complete IAB. -Baseline PR interval less than 200ms -Baseline HR less than 60/min or an average heart rate on baseline holter that is less than 65/min
Exclusion criteria
Exclusion criteria: -Persistent atrial fibrillation -History of corrected or uncorrected congenital heart disease -Severe mitral valve disease -Previous mitral surgery - Indication for Ventricular pacing -Pregnancy -Stage IV/V Chronic Kidney Disease -Multiple comorbidities with an estimated life expectancy more than 1 year -Patients unable to give written or informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative Change in N-proBNP compared with baselineTimepoint: 4 weeks 8 weeks 12 weeks and 24 weeks (derived from the study duration of 24 months with key intervals likely aligned with the washout period and follow-up phases) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Diastolic function assessment by echocardiography 2) HF Hospitalizations 3) Kansas City Cardiomyopathy Questionnaire 4) NYHA functional class, 5) 6WMD 6) atrial arrhythmia burden 7) daily diuretic requirement.Timepoint: 4 weeks 8 weeks 12 weeks & 24 weeks (derived from the study duration of 24 months with key intervals likely aligned with the washout period & follow-up phases). | — |
Countries
India
Contacts
Public ContactDr Daljeet saggu
Asian Institute Of Gastroenterology
Outcome results
None listed