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Procedure
Pacing Rates for Atrial Fibrillation (OPT-RATE AF Trial)
N/A
Recruiting
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Clinical HF diagnosis or NYHA class II or higher
Must not have
Infiltrative cardiomyopathy (CM)
ESRD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Summary
"This trial will test if a heart pacing rate of 80 beats per minute is better than the current standard of 60 beats per minute in improving quality of life and patient function over 3 months.
Who is the study for?
This trial is for adults over 18 with a history of atrial fibrillation, heart failure or NYHA class II or higher. They must have had CRT or pacing system implantation within the last 3-5 years and not be pregnant, in palliative care, or have life-threatening conditions like severe cardiomyopathy, end-stage renal disease, uncontrolled hypertension, significant lung disease on oxygen therapy, end stage cancer diagnosis.
What is being tested?
The study aims to see if setting a cardiac pacemaker to work at 80 beats per minute (bpm) improves patients' quality of life compared to the standard rate of 60 bpm. Participants will experience both rates for three months each in a randomized order to compare effects.
What are the potential side effects?
Potential side effects may include discomfort from increased heart rate such as palpitations or light-headedness. There could also be risks associated with changes in pacing settings affecting heart function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with heart failure or my condition limits my physical activity.
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I have a history of ongoing or permanent irregular heartbeat.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with infiltrative cardiomyopathy.
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I have end-stage renal disease.
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I need home oxygen for a lung condition.
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My condition is diagnosed as end-stage cancer.
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I am receiving care focused on relieving symptoms, not curing my disease.
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I have a hole in my heart that hasn't been fixed.
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I am over 90 years old.
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I cannot walk for six minutes due to major orthopedic issues.
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I have a serious heart valve problem.
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I have severe heart artery blockage or had a recent heart procedure.
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I have been diagnosed with hypertrophic cardiomyopathy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Function as measured by the Kansas City Cardiomyopathy Questionnaire
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
Secondary outcome measures
Change in B-type natriuretic peptide (BNP)
Change in New York Heart Association Class
Change in creatinine
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 80 bpm, then 60 bpmExperimental Treatment2 Interventions
Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months.
Group II: 60 bpm, then 80 bpmExperimental Treatment2 Interventions
Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months.
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Who is running the clinical trial?
Medstar Health Research InstituteLead Sponsor
193 Previous Clinical Trials
118,034 Total Patients Enrolled
MedtronicIndustry Sponsor
613 Previous Clinical Trials
759,533 Total Patients Enrolled
65 Trials studying Atrial Fibrillation
19,222 Patients Enrolled for Atrial Fibrillation
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