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โ† Trials
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RAFT - Pace &Ablate

RecruitingNAAges 18 Years - anyAllHabib Khan
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 600 ng/L * for those โ‰ฅ 75 years of age with an NT-proBNP โ‰ฅ 900 ng/L, or โ‰ฅ 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 โ‰ค 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)
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What it tests

  • Pace and Ablate
  • Medication
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Where

12 sites
Victoria Cardiac Arrhythmia Trials
Victoria, Canada
Nova Scotia Health Authority
Halifax, Canada
Hamilton Health Sciences Corporation
Hamilton, Canada
Waterloo Wellington Cardiovascular Research Institute
Kitchener, Canada
London Health Sciences Centre - University Hospital
London, Canada
Southlake Regional Health Centre
Newmarket, Canada
Ottawa Heart Institute Research Corporation
Ottawa, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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