Symptomatic heart failure with preserved ejection fraction (LVEF >= 50%)
Conditions
Interventions
- Enrolled subjects will be implanted with a Medtronic pacing system with a right ventricular (RV) lead placed in the conduction system (e.g., left bundle branch area or His bundle or the deep ventric
Sponsors
Harada Kei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age >=40 years 2.Documented EF >=50% within the preceding 12 months 3.HFpEF defined as + Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR + Dyspnea on exertion and NYHA >= II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA: - Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure - Elevated NT-proBNP in the last year defined as >400 pg/ml for patients with no AF or paroxysmal AF, or >900 pg/ml for patients with >=persistent AF - Mean PCWP >=15 mm Hg or LVEDP >=16 mm Hg at rest on cardiac catheterization OR PADP >=15 mm Hg at rest on implantable monitor (e.g. CardioMEMs). - Echo criteria defined by >=2 of: -- LV wall thickness >=12mm -- LV mass index (BSA indexed LVH): sex at birth male >115 g/m2, sex at birth female >95 g/m2 -- Relative wall thickness >=0.42 -- E/e' >=15 in sinus rhythm (or > 11 in the setting of atrial fibrillation) OR septal e' 2.8 m/s -- LA enlargement, defined by LA volume index >34 ml/m2 4.Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days 5.Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible) 6.Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).
Exclusion criteria
Exclusion criteria: 1.Improved or recovered EF (i.e., prior LVEF45. 8.Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate 160/100 mmHg on two measurements >=15 minutes apart 13.End Stage Renal Disease (CKD 4 or greater) 14.More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease) 15.Significant primary pulmonary disease on home oxygen 16.Known contraindication for a pacemaker implant 17.Advanced co-morbidity with life expectancy < 1 year 18.Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager. 19.Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Objective: Assess the effect of a personalized cardiac pacing rate in people with HFpEF on outcomes during the 12-month follow-up period. Primary Safety Objective: Assess the safety of dual chamber physiological pacing therapy in people with HFpEF. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Compare changes in HF-related health status as measured by the KCCQ-CSS from baseline to 12-months between randomized treatment groups. 2.Compare change in NT-proBNP from baseline to 12-months between randomized treatment groups. 3.Compare AF burden between randomized treatment groups during the 12-month follow-up period. 4.Compare change in 6-minute walk from baseline to 12-months between randomized treatment groups. 5.Compare device measured physical activity between randomized treatment groups during the 12-month follow-up period. | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Japan, Malaysia, Norway, Slovenia, Switzerland, United Kingdom, United States
Contacts
Public ContactKei Harada
Medtronic Japan Co., Ltd.
Outcome results
None listed