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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

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 more

Trial 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.

0 / 14Eligibility criteria met

Find a Location

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

~105 spots leftby Aug 2025

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