RAFT-P&A Randomized Control Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299514
• Other study ID #: 4754
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmia Atrial
• Atrial Fibrillation
• Heart Failure
• Pacemaker

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