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.
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Inclusion
- Patients with atrial fibrillation (AF) where AVNA is being considered Are on optimal heart failure therapies for ≥4 weeks
- NYHA class I-IVa
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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.
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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
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