Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. 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). There is 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 CSP with AV node ablation to optimal medical therapy for treating AF.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with permanent AF/persistent AF (in AF)

• Patients with NYHA Class II -IVa HF symptoms

• 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

Locations
Other Locations
Canada
London Health Sciences Centre - University Hospital
RECRUITING
London
London Health Sciences Research
NOT_YET_RECRUITING
London
Contact Information
Primary
Habib R Khan, MBBS, PhD
habib.khan@lhsc.on.ca
519-6633746
Backup
Abbie Pardo
abbie.pardo@lhsc.on.ca
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 600
Treatments
Active_comparator: Pharmacological Therapy
Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35%
Experimental: P&A-CSP
Patients randomized to P\&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov