Syncope, Vasovagal — Cardioneuroablation and Ventricular Proarrhythmia
Citation(s)
Brack KE, Coote JH, Ng GA Vagus nerve stimulation protects against ventricular fibrillation independent of muscarinic receptor activation. Cardiovasc Res. 2011 Aug 1;91(3):437-46. doi: 10.1093/cvr/cvr105. Epub 2011 May 16.
Chakraborty P, Chen PS, Gollob MH, Olshansky B, Po SS Potential consequences of cardioneuroablation for vasovagal syncope: A call for appropriately designed, sham-controlled clinical trials. Heart Rhythm. 2024 Apr;21(4):464-470. doi: 10.1016/j.hrthm.2023.12.004. Epub 2023 Dec 16.
Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.20
Zhu C, Hanna P, Rajendran PS, Shivkumar K Neuromodulation for Ventricular Tachycardia and Atrial Fibrillation: A Clinical Scenario-Based Review. JACC Clin Electrophysiol. 2019 Aug;5(8):881-896. doi: 10.1016/j.jacep.2019.06.009. Epub 2019 Aug 19.
Acute electRophysiOlogical Changes of Ventricular Myocardium Following cArdioneuroablatioN for Asystolic Reflex Syncope
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
