Optimal Pacing Rate for Cardiac Resynchronization Therapy (OPT-RATE AF)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation, Persistent
• Intervention / Treatment: Device: Pacing rate of 80 bpm; Device: Pacing rate of 60 bpm

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarahfaye Dolman; Phone Number: 302-530-1873; Email: Sarahfaye.F.Dolman@medstar.net

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
      • Contact: Sarahfaye Dolman; Phone Number: 3025301873; Email: Sarahfaye.F.Dolman@medstar.net
      • Contact: Athanasios Thomaides, MD
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
      • Contact: Sarahfaye Dolman; Phone Number: 3025301873; Email: Sarahfaye.F.Dolman@medstar.net
      • Contact: Athanasios Thomaides, MD
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Not yet recruiting
      • MedStar Union Memorial Hospital
      • Contact: Athanasios Thomaides, MD
      • Contact: Sarahfaye Dolman, MPH; Phone Number: 302-530-1873; Email: sarahfaye.f.dolman@medstar.net
    • Clinton, Maryland, United States, 20735
      • Recruiting
      • MedStar Southern Maryland Hospital
      • Contact: Sarahfaye Dolman; Phone Number: 3025301873; Email: Sarahfaye.F.Dolman@medstar.net
      • Contact: Athanasios Thomaides, MD
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • MedStar Heart and Vascular Office at Fairfax
      • Contact: Sarahfaye Dolman; Phone Number: 3025301873; Email: Sarahfaye.F.Dolman@medstar.net
      • Contact: Athanasios Thomaides, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older
2. History of persistent or permanent atrial fibrillation
3. Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
4. History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
5. LVEF ≥ 50%
6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) >400 pg/mL in the last 24 months
7. Clinical HF diagnosis or NYHA class II or higher
8. Able to provide informed consent

Exclusion Criteria:

1. LVEF <50%
2. Wide QRS (greater than 150ms)
3. Isolated RV pacing
4. Severe valvular disease

5. Severe coronary artery disease as defined by one of the following:

   1. ACS or PCI within 1 year
   2. Any angina (CCS class 1+)
   3. Unrevascularizable severe CAD (>70% stenosis in 1+ major vessels and/or based on functional assessment)
6. ESRD
7. Significant primary pulmonary disease on home oxygen
8. Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
9. Ventricular ectopy >15% premature ventricular contractions (PVC)
10. End stage cancer diagnosis
11. Life expectancy less than one year
12. Palliative or hospice care
13. Hypertrophic cardiomyopathy (HCM)
14. Uncorrected ventricular septal defect
15. Infiltrative cardiomyopathy (CM)
16. Uncontrolled hypertension as defined by blood pressure >160/100 mm Hg on two measurements ≥15 minutes apart
17. Hemoglobin <7 g/dL
18. Age >90 years old
19. Pregnant or intends to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 60 bpm, then 80 bpm; Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months.	Device: Pacing rate of 80 bpm; Pacing rate of 80 bpm; Device: Pacing rate of 60 bpm; Pacing rate of 60 bpm
Experimental: 80 bpm, then 60 bpm; Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months.	Device: Pacing rate of 80 bpm; Pacing rate of 80 bpm; Device: Pacing rate of 60 bpm; Pacing rate of 60 bpm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise tolerance as measured by the Six-Minute Walk Test	Exercise tolerance as measured by the Six-Minute Walk Test	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire	Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire	3 months
Function as measured by the International Physical Activity Questionnaire	Function as measured by the International Physical Activity Questionnaire	3 months
Change in B-type natriuretic peptide (BNP)	Change in B-type natriuretic peptide (BNP)	3 months
Change in creatinine	Change in creatinine	3 months
Change in New York Heart Association Class	Change in New York Heart Association Class	3 months
Atrial fibrillation burden	Atrial fibrillation burden as measured by pacemaker	3 months
Hospitalization for heart failure	Hospitalization for heart failure	3 months
Death due to heart failure	Death due to heart failure	3 months
Death due to myocardial infarction	Death due to myocardial infarction	3 months
Death due to stroke	Death due to stroke	3 months
Hospitalization for atrial fibrillation	Hospitalization for atrial fibrillation	3 months
Administration of loop diuretic/anti-arrhythmic drug	Administration of loop diuretic/anti-arrhythmic drug	3 months

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: Medtronic
• Investigators: Principal Investigator: Athanasios Thomaides, MD, MedStar Health

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STUDY00006952

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data available from PI upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No