RAFT-P&A Randomized Control Trial

Not Applicable

Recruiting

• Conditions: Heart Failure; Pacemaker; Atrial Fibrillation; Arrhythmia Atrial
• Interventions: Drug: Medication; Device: Pace and Ablate

• Registration Number: NCT06299514
• Lead Sponsor: Lawson Health Research Institute

Brief 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). There is 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 CSP with AV node ablation to optimal medical therapy for treating AF.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-08
• Study Start: 2024-04-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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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 1 year
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 requiring oxygenation
8. Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension
9. Patients enrolled in competitive clinical trials that will affect the objectives of this study
10. Existing CRT/BiVP
11. Patients who are pregnant or intend to become pregnant
12. Guideline indication for CRT

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacological Therapy	Medication	Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35%
P&A-CSP	Pace and Ablate	Patients randomized to P\&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.

Primary Outcome Measures

Name	Time	Method
Winratio	12 months	Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, and improvement in QOL.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	12 months	Mortality from any cause within the 12 month of follow up period
Cardiovascular mortality	12 months	Mortality attributed to cardiovascular causes within 12 month follow up period
Number of heart failure events	12 months	Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay
All-cause hospitalization	12 months	ER admission or overnight stay
Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ)	6 months	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.
Exercise	6 months	change in 6 minute walk distance from baseline
Biochemical marker	6 months	Change in NTproBNP from baseline
Cognitive assessment	12 months	Change in cognitive assessment scores from baseline

Trial Locations

Locations (2)

London Health Sciences Research; 🇨🇦 London, Ontario, Canada

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada