Optimal Pacing Rate for Cardiac Resynchronization Therapy
Recruiting · NCT06445439 · Interventional (participants receive a specific treatment) · Lead sponsor: Medstar Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Pacing rate of 60 bpmPacing rate of 80 bpm
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
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:
- 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
Where it is running
10 locations listed across 3 US states.
- MedStar Georgetown University Hospital - Washington D.C., District of Columbia, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- MedStar Georgetown University Hospital - Washington D.C., District of Columbia, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- MedStar Union Memorial Hospital - Baltimore, Maryland, United States
- MedStar Union Memorial Hospital - Baltimore, Maryland, United States
- MedStar Southern Maryland Hospital - Clinton, Maryland, United States
- MedStar Southern Maryland Hospital - Clinton, Maryland, United States
- MedStar Heart and Vascular Office at Fairfax - Fairfax, Virginia, United States
- MedStar Heart and Vascular Office at Fairfax - Fairfax, Virginia, United States