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Optimal Pacing Rate for Cardiac Resynchronization Therapy
NCT06445439 · Medstar Health Research Institute
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure
About this study
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.
Eligibility criteria
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 design
Enrollment target: 60 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-12-19
Estimated completion: 2025-08
Last updated: 2024-10-15
Interventions
Device: Pacing rate of 80 bpmDevice: Pacing rate of 60 bpm
Primary outcomes
- • Exercise tolerance as measured by the Six-Minute Walk Test (3 months)
Sponsor
Medstar Health Research Institute · other
With: Medtronic
Contacts & investigators
ContactSarahfaye Dolman · contact · Sarahfaye.F.Dolman@medstar.net · 302-530-1873
InvestigatorAthanasios Thomaides, MD · principal_investigator, MedStar Health
All locations (5)
MedStar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
MedStar Washington Hospital CenterRecruiting
Washington D.C., District of Columbia, United States
MedStar Union Memorial HospitalNot Yet Recruiting
Baltimore, Maryland, United States
MedStar Southern Maryland HospitalRecruiting
Clinton, Maryland, United States
MedStar Heart and Vascular Office at FairfaxRecruiting
Fairfax, Virginia, United States