Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
NCT ID: NCT02145351
Last Updated: 2023-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2014-04-07
2022-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Pacing off first, then pacing on
No-pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing on for an additional 4 weeks.
Rate adaptive atrial pacing using a dual-chamber pacemaker
The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.
Pacemaker system will be implanted but set to Pacing Off.
The identical pacing system will be implanted, but will be set to Pacing Off.
Pacing on first, then pacing off
Pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing off for an additional 4 weeks
Rate adaptive atrial pacing using a dual-chamber pacemaker
The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.
Pacemaker system will be implanted but set to Pacing Off.
The identical pacing system will be implanted, but will be set to Pacing Off.
Interventions
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Rate adaptive atrial pacing using a dual-chamber pacemaker
The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.
Pacemaker system will be implanted but set to Pacing Off.
The identical pacing system will be implanted, but will be set to Pacing Off.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
3. At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (≥14 average, ≥15 septal ) on echocardiography, Resting PCWP \>15 mm Hg or LV end-diastolic pressure \>18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure \>25 mmHg, or Elevated NT-proBNP level (≥300 pg/ml )
4. Left ventricular EF ≥40% within 12 months with clinical stability
5. Stable cardiac medical therapy for ≥30 days
6. Sinus rhythm
7. Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) \<0.80 or \<0.62 if on beta blockers
8. Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.
Exclusion Criteria
2. Any contraindication to a pacemaker system
3. Non-cardiac condition limiting life expectancy to less than one year
4. Significant left sided structural valve disease (\>mild stenosis, \>moderate regurgitation)
5. Hypertrophic cardiomyopathy
6. Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
7. Pericardial disease
8. Non-group 2 pulmonary arterial hypertension
9. Chronic stable exertional angina
10. Acute coronary syndrome or revascularization within 60 days
11. Other clinically important causes of dyspnea
12. Atrial fibrillation
13. PR interval \>210 msec
14. Resting heart rate (HR) \> 100 bpm
15. A history of reduced ejection fraction (EF\<40%)
16. Advanced chronic kidney disease (GFR \< 20 ml/min/1.73m2 by modified MDRD equation)
17. Women of child bearing potential without negative pregnancy test and effective contraception
18. Severe anemia (Hemoglobin \<10 g/dL)
19. Severe hepatic disease
20. Complex congenital heart disease
21. Listed for cardiac transplantation
22. Other class I indications for pacing
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Barry Borlaug
Principal Investigator
Principal Investigators
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Barry Borlaug, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Reddy YNV, Koepp KE, Carter R, Win S, Jain CC, Olson TP, Johnson BD, Rea R, Redfield MM, Borlaug BA. Rate-Adaptive Atrial Pacing for Heart Failure With Preserved Ejection Fraction: The RAPID-HF Randomized Clinical Trial. JAMA. 2023 Mar 14;329(10):801-809. doi: 10.1001/jama.2023.0675.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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13-008306
Identifier Type: -
Identifier Source: org_study_id
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