Optimal Pacing Rate for Cardiac Resynchronization Therapy

Atrial Fibrillation, Persistent Clinical Trial

— OPT-RATE AF  

Official title:

Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445439
• Other study ID #: STUDY00006952
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Medstar Health Research Institute
• Contact: Sarahfaye Dolman
• Phone: 302-530-1873
• Email: Sarahfaye.F.Dolman[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 quality of life (QoL) and patient function after 3 months of intervention compared to 3 months of the current standard 60 bpm. 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.

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 quality of life (QoL) and patient function after 3 months of intervention compared to 3 months of the current standard 60 bpm.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

Device:
• Pacing rate of 80 bpm
Pacing rate of 80 bpm
• Pacing rate of 60 bpm
Pacing rate of 60 bpm

Locations

Country	Name	City	State
United States	MedStar Southern Maryland Hospital	Clinton	Maryland
United States	MedStar Heart and Vascular Office at Fairfax	Fairfax	Virginia
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire	Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire	3 months
Primary	Function as measured by the Kansas City Cardiomyopathy Questionnaire	Function as measured by the Kansas City Cardiomyopathy Questionnaire	3 months
Secondary	Quality of life as measured by the Six-Minute Walk Test	Quality of life as measured by the Six-Minute Walk Test	3 months
Secondary	Function as measured by the International Physical Activity Questionnaire	Function as measured by the International Physical Activity Questionnaire	3 months
Secondary	Change in B-type natriuretic peptide (BNP)	Change in B-type natriuretic peptide (BNP)	3 months
Secondary	Change in creatinine	Change in creatinine	3 months
Secondary	Change in New York Heart Association Class	Change in New York Heart Association Class	3 months