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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.
Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.
This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test.
The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 bpm, then 80 bpm | Experimental | Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months. |
|
| 80 bpm, then 60 bpm | Experimental | Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing rate of 80 bpm | Device | Pacing rate of 80 bpm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise tolerance as measured by the Six-Minute Walk Test | Exercise tolerance as measured by the Six-Minute Walk Test | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire | Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire | 3 months |
| Function as measured by the International Physical Activity Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
LVEF <50%
Wide QRS (greater than 150ms)
Isolated RV pacing
Severe valvular disease
Severe coronary artery disease as defined by one of the following:
ESRD
Significant primary pulmonary disease on home oxygen
Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
Ventricular ectopy >15% premature ventricular contractions (PVC)
End stage cancer diagnosis
Life expectancy less than one year
Palliative or hospice care
Hypertrophic cardiomyopathy (HCM)
Uncorrected ventricular septal defect
Infiltrative cardiomyopathy (CM)
Uncontrolled hypertension as defined by blood pressure >160/100 mm Hg on two measurements ≥15 minutes apart
Hemoglobin <7 g/dL
Age >90 years old
Pregnant or intends to become pregnant
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarahfaye Dolman | Contact | 302-530-1873 | Sarahfaye.F.Dolman@medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Athanasios Thomaides, MD | MedStar Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
Study data available from PI upon request.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.
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| Pacing rate of 60 bpm | Device | Pacing rate of 60 bpm |
|
Function as measured by the International Physical Activity Questionnaire
| 3 months |
| Change in B-type natriuretic peptide (BNP) | Change in B-type natriuretic peptide (BNP) | 3 months |
| Change in creatinine | Change in creatinine | 3 months |
| Change in New York Heart Association Class | Change in New York Heart Association Class | 3 months |
| Atrial fibrillation burden | Atrial fibrillation burden as measured by pacemaker | 3 months |
| Hospitalization for heart failure | Hospitalization for heart failure | 3 months |
| Death due to heart failure | Death due to heart failure | 3 months |
| Death due to myocardial infarction | Death due to myocardial infarction | 3 months |
| Death due to stroke | Death due to stroke | 3 months |
| Hospitalization for atrial fibrillation | Hospitalization for atrial fibrillation | 3 months |
| Administration of loop diuretic/anti-arrhythmic drug | Administration of loop diuretic/anti-arrhythmic drug | 3 months |
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| MedStar Union Memorial Hospital | Not yet recruiting | Baltimore | Maryland | 21218 | United States |
|
| MedStar Southern Maryland Hospital | Recruiting | Clinton | Maryland | 20735 | United States |
|
| MedStar Heart and Vascular Office at Fairfax | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |