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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF > 35%, and LBBB.
This pilot study will be a multicenter randomized controlled trial involving 20 medically stable outpatients with heart failure (HF), preserved or mildly reduced LVEF (>35%), and LBBB. Patients will undergo implantation of a Medtronic Percepta CRT-P with an atrial lead, left bundle branch area pacing (LBBap) lead, and a LV lead. They will then be randomly allocated in a 1:1 fashion to usual care plus LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) or usual care plus BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group |
|
| Sequence 2 | Experimental | BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB-CRT | Device | LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in myocardial performance index (MPI) as compared to Baseline | Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging. | Baseline and 3 month treatment period after each pacing mode |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Atwater, MD | Inova Health Care Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Inova Health System |
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single arm crossover study
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| BIV-CRT | Device | BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2). |
|
| Falls Church |
| Virginia |
| 22042 |
| United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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