Controlling heart rate in patients with atrial fibrillation using a pacemaker and ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate a novel approach for managing atrial fibrillation (AF) in patients who have heart failure symptoms. The method involves implanting a pacemaker and performing ablation on the atrioventricular (AV) node to regulate heart rhythm effectively. By intentionally damaging the AV node, the trial seeks to prevent AF from affecting the heart's ventricles, allowing the pacemaker to maintain a stable heart rate. This approach is particularly targeted at patients who struggle with medication side effects or ineffective treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with permanent AF/persistent AF (in AF)
2. Patients with NYHA Class II -IVa HF symptoms
3. Guideline driven medical therapy (GDMT) for HF for at least 3 months:

   * for those \< 75 years of age with an NT-proBNP of ≥ 600 ng/L
   * for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year

Exclusion Criteria:

1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
3. Acute coronary syndrome \<4 weeks or coronary revascularization \<3months
4. Unable or unwilling to provide informed consent
5. Uncorrected primary valvular disease or prosthetic tricuspid valve
6. Restrictive, hypertrophic, or irreversible form of cardiomyopathy
7. Severe pulmonary diseases requiring oxygenation
8. 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
9. Patients enrolled in competitive clinical trials that will affect the objectives of this study
10. Existing CRT/BiVP
11. Patients who are pregnant
12. Guideline indication for CRT
13. More than 20% pacing with an existing pacemaker
14. Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)

Where it's running

• Victoria Cardiac Arrhythmia Trials
  Victoria, British Columbia, Canada Recruiting
• Nova Scotia Health Authority
  Halifax, Nova Scotia, Canada Recruiting
• Hamilton Health Sciences Corporation
  Hamilton, Ontario, Canada Recruiting
• Waterloo Wellington Cardiovascular Research Institute
  Kitchener, Ontario, Canada Recruiting
• London Health Sciences Centre - University Hospital
  London, Ontario, Canada Recruiting
• Southlake Regional Health Centre
  Newmarket, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Habib R Khan, MBBS, PhD
• Email: habib.khan@lhsc.on.ca
• Phone: 519-6633746

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Village-doctor–led telehealth care to improve outcomes for AF and HF in older adults

  A village doctor–led telemedicine program will try to improve heart failure management in rural AF patients aged 65–80 compared with usual care.

  Recruiting at 3 sites Jiangsu Taizhou People's Hospital · Yancheng, Dongtai and 2 other locations · NCT07492524

• Village doctor–led telehealth care to prevent heart failure in AF patients

  A village doctor–led telehealth program tests whether integrated, guideline-based care can help older adults with atrial fibrillation in rural China stay healthier and avoid heart failure compared with usual care.

  Recruiting at 3 sites Jiangsu Taizhou People's Hospital · Yancheng, Dongtai and 2 other locations · NCT07492498

• RHYthm and Myocardial Function Relationship in Heart Disease

  This study tests how heart rhythm patterns relate to heart muscle function in adults with arrhythmias or cardiomyopathy.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07491237

• Longitudinal Assessment of Cardiac MRI Microstructure in Patients and Healthy People

  This study tests advanced, non-contrast and extended clinical cardiac MRI techniques to see how heart tissue features differ between people with heart disease and healthy individuals.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07081711

• Using BIOMONITOR IV to track heart rhythm and warning signs in people with heart failure

  This project will test whether a small implanted monitor called BIOMONITOR IV can track irregular heartbeats and body signals in people with heart failure who do not have ICD/CRT devices to see if it can warn doctors before the heart failure gets worse.

  Recruiting Biotronik SE & Co. KG · Genk and 1 other locations · NCT06989580

• Understanding brain and heart injuries after bleeding in the brain

  This study looks at how bleeding in the brain affects both the brain and the heart in adults to better understand the connection between these injuries.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT06906432

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.