Status:
ACTIVE_NOT_RECRUITING
Resynchronization in Patients With HF in AF Trial Undergoing Pace & AVNA Strategy With LBBAP Compared With BiV Pacing
Lead Sponsor:
Habib Khan
Collaborating Sponsors:
London Health Sciences Centre
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This trial will compare two management strategies for HF patients with Atrial Fibrillation. The active control group will undergo BiV pacing, followed by an AV node ablation. The experimental group wi...
Detailed Description
This is a prospective, randomized, double blind, control trial with follow up visits at 6- and 12-months following randomization. Patients will be randomized in a 1:1 allocation to either the control ...
Eligibility Criteria
Inclusion
- Patients with atrial fibrillation (AF) where AVNA is being considered with or without a pacemaker
- Are on optimal heart failure therapies for ≥4 weeks
- NYHA class I-IVa
- Patients deemed not appropriate for rhythm control strategy (only for rate control strategy).
- Failed Ablation (≥1 failed ablation attempt)
- Refractory or intolerant to Antiarrhythmic drugs AADs or rate control medications
- Patient choice not to have rhythm control strategies
- Being considered for AVNA
- Patients with baseline NT-proBNP\>600 or \>400 if HF hospitalization within 12 months.
Exclusion
- In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
- Acute coronary syndrome (including MI) or Coronary revascularization (CABG or PCI) \<3 months
- Uncorrected or uncorrectable primary moderate to severe valvular disease
- TAVI \< 3 months
- Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
- Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
- Pulmonary hypertension (Mean pulmonary pressure is ≥35 mm Hg)
- Patients with a life expectancy of less than one year from non-cardiac cause
- Patients included in other clinical trials that will affect the objectives of this study or have competing interests
- Those unable or unwilling to provide informed consent unless supported by legal power of attorney
- Active malignancy with likelihood of survival \<1 year
- NYHA class IVb
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT05428787
Start Date
September 26 2022
End Date
December 31 2024
Last Update
June 7 2024
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada