Atrial Fibrillation, Persistent
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPacing rate of 80 bpm
Pacing rate of 80 bpm
DEVICEPacing rate of 60 bpm
Pacing rate of 60 bpm
Sponsors
Medtronic
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. History of persistent or permanent atrial fibrillation 3. Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start 4. History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start 5. LVEF ≥ 50% 6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>400 pg/mL in the last 24 months 7. Clinical HF diagnosis or NYHA class II or higher 8. Able to provide informed consent
Exclusion criteria
1. LVEF \<50% 2. Wide QRS (greater than 150ms) 3. Isolated RV pacing 4. Severe valvular disease 5. Severe coronary artery disease as defined by one of the following: 1. ACS or PCI within 1 year 2. Any angina (CCS class 1+) 3. Unrevascularizable severe CAD (\>70% stenosis in 1+ major vessels and/or based on functional assessment) 6. ESRD 7. Significant primary pulmonary disease on home oxygen 8. Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test 9. Ventricular ectopy \>15% premature ventricular contractions (PVC) 10. End stage cancer diagnosis 11. Life expectancy less than one year 12. Palliative or hospice care 13. Hypertrophic cardiomyopathy (HCM) 14. Uncorrected ventricular septal defect 15. Infiltrative cardiomyopathy (CM) 16. Uncontrolled hypertension as defined by blood pressure \>160/100 mm Hg on two measurements ≥15 minutes apart 17. Hemoglobin \<7 g/dL 18. Age \>90 years old 19. Pregnant or intends to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise tolerance as measured by the Six-Minute Walk Test | 3 months | Exercise tolerance as measured by the Six-Minute Walk Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function as measured by the International Physical Activity Questionnaire | 3 months | Function as measured by the International Physical Activity Questionnaire |
| Change in B-type natriuretic peptide (BNP) | 3 months | Change in B-type natriuretic peptide (BNP) |
| Change in creatinine | 3 months | Change in creatinine |
| Change in New York Heart Association Class | 3 months | Change in New York Heart Association Class |
| Atrial fibrillation burden | 3 months | Atrial fibrillation burden as measured by pacemaker |
| Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire | 3 months | Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire |
| Death due to heart failure | 3 months | Death due to heart failure |
| Death due to myocardial infarction | 3 months | Death due to myocardial infarction |
| Death due to stroke | 3 months | Death due to stroke |
| Hospitalization for atrial fibrillation | 3 months | Hospitalization for atrial fibrillation |
| Administration of loop diuretic/anti-arrhythmic drug | 3 months | Administration of loop diuretic/anti-arrhythmic drug |
| Hospitalization for heart failure | 3 months | Hospitalization for heart failure |
Countries
United States
Contacts
Primary ContactSarahfaye Dolman
Outcome results
None listed