Heart Failure Clinical Trial
Official title:
Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Bi-Ventricular or Conduction System Pacing
NCT number | NCT06299514 |
Other study ID # | 4754 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 25, 2024 |
Est. completion date | December 31, 2029 |
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 31, 2029 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. . Patients with permanent AF/persistent AF (in AF) 2. . Patients with NYHA Class II -IVa HF symptoms 3. . NT-proBNP = 900 ng/L, or = 600 ng/L if the patient has had a HF hospitalization within 1 year despite of guideline-driven medical therapy for HF of at least 3 months 4. . any QRS duration for patients with LVEF >35%, QRS duration <150 ms for patients with LVEF =35% Exclusion Criteria: 1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days 2. patients with a life expectancy of = 1 year from non-cardiac cause or anticipating a transplant within 1year 3. acute coronary syndrome <4 weeks or coronary revascularization <3months 4. unable or unwilling to provide informed consent 5. uncorrected primary valvular disease or prosthetic tricuspid valve 6. restrictive, hypertrophic, or reversible form of cardiomyopathy 7. severe pulmonary diseases such as cor pulmonale or pulmonary hypertension (=35mmHg) 8. patients enrolled in competitive clinical trials that will affect the objectives of this study; 9. existing CRT/BiVP or pacemaker 10. resting heart rate =110 bpm on Holter monitoring 11. patients who are pregnant or intend to become pregnant |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre - University Hospital | London | Ontario |
Canada | London Health Sciences Research | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Winratio | Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, and improvement in QOL. | 12 months | |
Secondary | All-cause mortality | Mortality from any cause within the 12 month of follow up period | 12 months | |
Secondary | Cardiovascular mortality | Mortality attributed to cardiovascular causes within 12 month follow up period | 12 months | |
Secondary | Number of heart failure events | Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay | 12 months | |
Secondary | All-cause hospitalization | ER admission or overnight stay | 12 months | |
Secondary | Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ) | Change in Kansas HF score from baseline. KCCQ is a 23-item self-administered questionnaire that measures the participant's perception of their health status, including their HF symptoms, impact on physical and social function and how their HF impacts the quality of life (QoL). KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), QoL (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. | 6 months | |
Secondary | Exercise | change in 6 minute walk distance from baseline | 6 months | |
Secondary | Biochemical marker | Change in NTproBNP from baseline | 6 months |
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