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 (RAFT P&A RCT)
RAFT P&A RCT
Lead PI & Sponsor
Dr. Habib Khan
Local PI
Dr. Habib Khan
Research Staff
Noran Abou-Zaid
Objective
The primary objective of the trial is to evaluate the optimal strategy to manage patients with permanent AF and HF, evaluating pharmacological therapies and P&A-CSP strategy, that reduces mortality, HF hospitalizations, reduces NT-proBNP and improves Qol. The secondary objectives of the trial are to evaluate measured responses to all strategies using biochemical changes such as NT-proBNP, 6-minute walk distance {6MWD) and impact on cardiac function (echocardiogram). Alongside these patient-driven objectives, the trial also aims to evaluate the efficacy and safety of the CSP-P&A strategy compared to pharmacological therapy.
Target Number of Patients
80
Currently Enrolled
14
Primary Outcomes
- Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP, and improvement in QOL.
Secondary Outcomes
- All-cause mortality
- Cardiovascular mortality
- Number of worsening of HF events (worsening HF signs requiring intravenous HF therapy, ultrafiltration at a healthcare facility, or hospitalization for HF of~ 24 hours)
- All-cause hospitalization
- Changes in Kansas City Cardiomyopathy Questionnaire-overall summary score (KCCQ-OSS) at 6 months from baseline
- 6MWD change at 6 months from baseline
- NT-proBNP change at 6 months from baseline
- Changes in cognitive function assessed by memory, reasoning, verbal ability and concentration
Inclusion Criteria
- Patients with permanent AF/persistent AF
- Patients with NYHA Class II -IVa HF symptoms
- Guideline driven medical therapy (GDMT) 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
- In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of ~ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- Acute coronary syndrome < 4 weeks or coronary revascularization < 3 months
- Unable or unwilling to provide informed consent
- Uncorrected primary valvular disease or prosthetic tricuspid valve
- Restrictive, hypertrophic, or irreversible form of cardiomyopathy
- Severe pulmonary diseases requiring oxygenation
- 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
- Patients enrolled in competitive clinical trials that will affect the objectives of this study
- Existing CRT /BiVP
- Patients who are pregnant
- Guideline indication for CRT
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.