Determining the best pacing rate for heart therapy in patients with atrial fibrillation

Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure

This study is testing if a heart pacing rate of 80 beats per minute can help people with atrial fibrillation exercise better and feel healthier compared to a rate of 60 beats per minute.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Medstar Health Research Institute (Academic / other)
• Locations: 5 sites (Washington D.C., District of Columbia and 4 other locations)
• Trial ID: NCT06445439 on ClinicalTrials.gov

What this trial studies

This prospective, randomized crossover study aims to evaluate whether a pacing rate of 80 beats per minute (bpm) enhances exercise tolerance in patients with persistent atrial fibrillation undergoing cardiac resynchronization therapy. Participants will be randomly assigned to start at either 60 bpm or 80 bpm for three months, after which they will switch rates. The study will assess various health metrics, including exercise capacity measured by the 6-minute walk test, and track patient outcomes such as mortality and heart failure hospitalizations. The goal is to identify the optimal pacing rate that may improve patient quality of life and exercise performance.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of persistent or permanent atrial fibrillation and specific heart failure criteria.

Not a fit: Patients with a left ventricular ejection fraction below 50% or severe coronary artery disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved exercise tolerance and overall quality of life for patients with persistent atrial fibrillation and heart failure.

How similar studies have performed: While similar studies have explored pacing rates in heart failure, this specific approach remains novel and untested.

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

Where this trial is running

Washington D.C., District of Columbia and 4 other locations

• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (Recruiting)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States (Not_yet_recruiting)
• MedStar Southern Maryland Hospital — Clinton, Maryland, United States (Recruiting)
• MedStar Heart and Vascular Office at Fairfax — Fairfax, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Athanasios Thomaides, MD — MedStar Health
• Study coordinator: Sarahfaye Dolman

Conditions Atrial Fibrillation, Persistent