NCT06445439 · Medstar Health Research Institute
Optimal Pacing Rate for Cardiac Resynchronization Therapy
(OPT-RATE AF)
What this study is about
This is a forward-looking, randomly assigned 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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)
- 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
- Washington D.C., District of Columbia
- Baltimore, Maryland
- Clinton, Maryland
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2024 · Source of record for eligibility and locations