RAFT - Pace &Ablate

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Mar 1, 2024

Keywords

ClinConnect Summary

The RAFT-P&A trial is studying how well a new heart pacing technique called Conduction System Pacing (CSP) works compared to standard medical treatments for patients with a condition called atrial fibrillation (AF) and heart failure. AF is when the heart beats irregularly, which can lead to various health issues. In some cases, doctors may use a pacemaker combined with a procedure to help control the heart's rhythm more effectively, especially for patients who have difficulty with medications. The trial will compare this new approach to the best available drug treatments to see which is more effective in managing symptoms and improving patients' heart health.

To participate in this trial, patients should be between 65 to 74 years old and have permanent or persistent AF along with moderate to severe heart failure symptoms. Other specific health criteria apply, but those who are hospitalized for serious heart issues or have certain other conditions may not be eligible. Participants will receive careful monitoring and treatment throughout the study, and their experiences will help determine if CSP is a better option for managing AF than traditional medications. This research aims to improve treatment options for patients who struggle with AF and heart failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with permanent AF/persistent AF (in AF)
• • 2. Patients with NYHA Class II -IVa HF symptoms
• • 3. Guideline driven medical therapy for HF for at least 3- months with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year
• 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 irreversible 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