Atrial Fibrillation, PersistentOPT-RATE AFNCT06445439
Optimal Pacing Rate for Cardiac Resynchronization Therapy
A study testing Pacing rate of 80 bpm and Pacing rate of 60 bpm in people with Atrial Fibrillation, Persistent, run by Medstar Health Research Institute at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Pacing rate of 80 bpm and Pacing rate of 60 bpm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Dec 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Sarahfaye Dolman, MPH, 302-530-1873, sarahfaye.f.dolman@medstar.net
Athanasios Thomaides, MD
- Recruiting
MedStar Southern Maryland Hospital
Clinton, Maryland, 20735
Sarahfaye Dolman, 3025301873, Sarahfaye.F.Dolman@medstar.net
Athanasios Thomaides, MD
- Recruiting
MedStar Heart and Vascular Office at Fairfax
Fairfax, Virginia, 22031
Sarahfaye Dolman, 3025301873, Sarahfaye.F.Dolman@medstar.net
Athanasios Thomaides, MD
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Sarahfaye Dolman, 3025301873, Sarahfaye.F.Dolman@medstar.net
Athanasios Thomaides, MD
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Sarahfaye Dolman, 3025301873, Sarahfaye.F.Dolman@medstar.net
Athanasios Thomaides, MD
About this study
Official title: Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure
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.
Read the detailed description
Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.
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. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Pacing rate of 80 bpm, Pacing rate of 60 bpm
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing rate of 80 bpmDevice
Pacing rate of 80 bpm
Pacing rate of 60 bpmDevice
Pacing rate of 60 bpm
| Study group | Role | What they receive |
|---|---|---|
| 60 bpm, then 80 bpm | Experimental | Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months. Receives: Device: Pacing rate of 80 bpm; Device: Pacing rate of 60 bpm |
| 80 bpm, then 60 bpm | Experimental | Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months. Receives: Device: Pacing rate of 80 bpm; Device: Pacing rate of 60 bpm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance as measured by the Six-Minute Walk Test
Exercise tolerance as measured by the Six-Minute Walk Test
Measured: 3 months
Secondary outcomes (12)
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
Measured: 3 months
Function as measured by the International Physical Activity Questionnaire
Function as measured by the International Physical Activity Questionnaire
Measured: 3 months
Change in B-type natriuretic peptide (BNP)
Change in B-type natriuretic peptide (BNP)
Measured: 3 months
Change in creatinine
Change in creatinine
Measured: 3 months
Change in New York Heart Association Class
Change in New York Heart Association Class
Measured: 3 months
Atrial fibrillation burden
Atrial fibrillation burden as measured by pacemaker
Measured: 3 months
Hospitalization for heart failure
Hospitalization for heart failure
Measured: 3 months
Death due to heart failure
Death due to heart failure
Measured: 3 months
Death due to myocardial infarction
Death due to myocardial infarction
Measured: 3 months
Death due to stroke
Death due to stroke
Measured: 3 months
Hospitalization for atrial fibrillation
Hospitalization for atrial fibrillation
Measured: 3 months
Administration of loop diuretic/anti-arrhythmic drug
Administration of loop diuretic/anti-arrhythmic drug
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start19 Dec 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Athanasios Thomaides, MD, Principal investigator, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445439
- Sponsor's protocol ID
- STUDY00006952
- Acronym
- OPT-RATE AF
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study data available from PI upon request.
Publications
Czulada E, Smith JD, Kolm P, Deb B, Dolman SF, Alexander N, Braun RA, Kabadi RA, Weintraub WS, Strouse D, Thomaides A. Rationale and Design of OPT-RATE AF: A Randomized Clinical Trial of Increased Physiologic Pacing Rates in Heart Failure With Preserved Ejection Fraction. Am J Cardiol. 2025 Jan 1;234:1-8. doi: 10.1016/j.amjcard.2024.09.033. Epub 2024 Oct 18.
PubMed 39427696
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure
- ClinicalTrials.gov ID
- NCT06445439
- Acronym / sponsor ID
- OPT-RATE AF / STUDY00006952
- Conditions
- Atrial Fibrillation, Persistent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.
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. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 60 bpm, then 80 bpm | Experimental | Device: Pacing rate of 80 bpm, Device: Pacing rate of 60 bpmPacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months. |
| 80 bpm, then 60 bpm | Experimental | Device: Pacing rate of 80 bpm, Device: Pacing rate of 60 bpmPacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (22 listed)
- LVEF <50%
- Wide QRS (greater than 150ms)
- Isolated RV pacing
- Severe valvular disease
- Severe coronary artery disease as defined by one of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacing rate of 80 bpmPacing rate of 80 bpm | Device | 60 bpm, then 80 bpm, 80 bpm, then 60 bpm |
| Pacing rate of 60 bpmPacing rate of 60 bpm | Device | 60 bpm, then 80 bpm, 80 bpm, then 60 bpm |
Primary outcome
Exercise tolerance as measured by the Six-Minute Walk Test
Time frame: 3 months
Exercise tolerance as measured by the Six-Minute Walk Test
12 secondary outcomes
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
Time frame: 3 months
Function as measured by the International Physical Activity Questionnaire
Time frame: 3 months
Change in B-type natriuretic peptide (BNP)
Time frame: 3 months
Change in creatinine
Time frame: 3 months
Change in New York Heart Association Class
Time frame: 3 months
Atrial fibrillation burden
Time frame: 3 months
Hospitalization for heart failure
Time frame: 3 months
Death due to heart failure
Time frame: 3 months
Death due to myocardial infarction
Time frame: 3 months
Death due to stroke
Time frame: 3 months
Hospitalization for atrial fibrillation
Time frame: 3 months
Administration of loop diuretic/anti-arrhythmic drug
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39427696Czulada E, Smith JD, Kolm P, Deb B, Dolman SF, Alexander N, Braun RA, Kabadi RA, Weintraub WS, Strouse D, Thomaides A. Rationale and Design of OPT-RATE AF: A Randomized Clinical Trial of Increased Physiologic Pacing Rates in Heart Failure With Preserved Ejection Fraction. Am J Cardiol. 2025 Jan 1;234:1-8. doi: 10.1016/j.amjcard.2024.09.033. Epub 2024 Oct 18.
- Individual participant dataSharing planned: No. Study data available from PI upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Thomaides, MD principal investigator
MedStar Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing rate of 80 bpm and Pacing rate of 60 bpm in people with Atrial Fibrillation, Persistent, run by Medstar Health Research Institute at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarahfaye Dolman (302-530-1873, Sarahfaye.F.Dolman@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance as measured by the Six-Minute Walk Test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.