Clinical trial NCT06445439: Optimal Pacing Rate for Cardiac Resynchronization Therapy
Official title: Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2024-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise tolerance as measured by the Six-Minute Walk Test
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
timeFrame: 3 months
measure: Function as measured by the International Physical Activity Questionnaire
timeFrame: 3 months
measure: Change in B-type natriuretic peptide (BNP)
timeFrame: 3 months
measure: Change in creatinine
timeFrame: 3 months
measure: Change in New York Heart Association Class
timeFrame: 3 months
measure: Atrial fibrillation burden
timeFrame: 3 months
measure: Hospitalization for heart failure
timeFrame: 3 months
measure: Death due to heart failure
timeFrame: 3 months
measure: Death due to myocardial infarction
timeFrame: 3 months
measure: Death due to stroke
timeFrame: 3 months
measure: Hospitalization for atrial fibrillation
timeFrame: 3 months
measure: Administration of loop diuretic/anti-arrhythmic drug
timeFrame: 3 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Clinton
country: United States
facility: MedStar Southern Maryland Hospital
state: Maryland
city: Fairfax
country: United States
facility: MedStar Heart and Vascular Office at Fairfax
state: Virginia
Study officials:
affiliation: MedStar Health
name: Athanasios Thomaides, MD
role: PRINCIPAL_INVESTIGATOR
References: