RAFT-P&A

Resynchronization in Patients With HF in AF Trial Undergoing Pace & AVNA Strategy With LBBAP Compared With BiV Pacing

Objective

This trial will compare two management strategies for HF patients with Atrial Fibrillation: The active control group will undergo BiV pacing versus LBBAP, both followed by an AV node ablation. 

  1. Inclusion

    • Patients with atrial fibrillation (AF) where AVNA is being considered Are on optimal heart failure therapies for ≥4 weeks
    • NYHA class I-IVa
    • Patients deemed not appropriate for rhythm control strategy d/t:

      • Failed Ablation (≥1 failed ablation attempt)
      • Refractory or intolerant to AADs or rate control medications
      • Patient choice not to have rhythm control strategies

     

    •  Baseline NT-proBNP>600 or >400 if HF hospitalization within 12 months.
  2. Exclusion

    • In-hospital ICU
    • ACS, MI, CABG, PCI, TAVI  past 3 months
    • Uncorrected or uncorrectable primary moderate to severe valvular disease
    • Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
    • Severe/irreversible primary pulmonary disease requiring inhalers, oxygen supplementation
    • Pulmonary hypertension (Mean pulmonary pressure is ≥35 mm Hg)
    •  Life expectancy of less than one year from non-cardiac cause
    • In other clinical trial(s)
    • Unable or unwilling to provide informed consent 
    • NYHA class IVb
    • Pregnant or intend to be
Not Enrolling

Additional Info

Ethics ID: REB23-0162

ClinicalTrials.gov ID: NCT05428787

 

Sponsor: Lawson Health Research Institute

 

PI: Dr. Jacques Rizkallah

Phone: 403 944 8498 

 

Admin: Jennifer McKeage

Phone: 403 210 6047

Email: jmckeage@ucalgary.ca

Updated Sept 19, 2023