Optimal Pacing Rate for Cardiac Resynchronization Therapy
- Conditions
- Atrial Fibrillation, Persistent
- Interventions
- Device: Pacing rate of 80 bpmDevice: Pacing rate of 60 bpm
- Registration Number
- NCT06445439
- Lead Sponsor
- Medstar Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age 18 years or older
- History of persistent or permanent atrial fibrillation
- Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
- History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
- LVEF ≥ 50%
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) >400 pg/mL in the last 24 months
- Clinical HF diagnosis or NYHA class II or higher
- Able to provide informed consent
-
LVEF <50%
-
Wide QRS (greater than 150ms)
-
Isolated RV pacing
-
Severe valvular disease
-
Severe coronary artery disease as defined by one of the following:
- ACS or PCI within 1 year
- Any angina (CCS class 1+)
- Unrevascularizable severe CAD (>70% stenosis in 1+ major vessels and/or based on functional assessment)
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 80 bpm, then 60 bpm Pacing rate of 80 bpm Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months. 60 bpm, then 80 bpm Pacing rate of 80 bpm 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 Pacing rate of 60 bpm Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months. 60 bpm, then 80 bpm Pacing rate of 60 bpm Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months.
- Primary Outcome Measures
Name Time Method Exercise tolerance as measured by the Six-Minute Walk Test 3 months Exercise tolerance as measured by the Six-Minute Walk Test
- Secondary Outcome Measures
Name Time Method Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire 3 months Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
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
Hospitalization for heart failure 3 months Hospitalization for heart failure
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
Trial Locations
- Locations (5)
MedStar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
MedStar Southern Maryland Hospital
🇺🇸Clinton, Maryland, United States
MedStar Heart and Vascular Office at Fairfax
🇺🇸Fairfax, Virginia, United States