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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source Lawson Health Research Institute
Contact Habib R Khan, MBBS, PhD
Phone 519-6633746
Email habib.khan@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Pace and Ablate
BiVentricular Pacing (BiVP) or Conduction System Pacing(CSP) followed by AtrioVentricular Node Ablation (AVNA)
Drug:
Medication
Optimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis

Locations

Country Name City State
Canada London Health Sciences Centre - University Hospital London Ontario
Canada London Health Sciences Research London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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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