Clinical trial: Cardioneuroablation for Neurocardiogenic Syncope (NCT02009982)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is able and willing to sign and date the Patient Consent Form

          -  Subject is 18 years of age or older

          -  Subject is expected to remain available for the follow-up protocol

          -  Subject is willing to comply with the follow-up procedures

          -  Subject has medically documented history of neurocardiogenic syncope

          -  Subject has had 3 episodes of syncope or presyncope in last 12 months

          -  Subject has had a positive tilt table test, defined as the presence of syncope or
             presyncope associated with abrupt hypotension (SBP < 70 mmHg) or bradycardia (HR < 40
             bpm), with or without sublingual nitroglycerin provocation or atropine challenge

          -  Subject has been tried on at least one pharmacologic therapy for at least 4 weeks

        Exclusion Criteria:

          -  Subject has signs and symptoms of an active infection (i.e. fever, elevated white
             blood cell count, etc.) which has not been treated and/or has not demonstrated
             improvement in white blood cell count and resolution of fever

          -  Subject is pregnant or planning to become pregnant within the study protocol follow-up

          -  Subject is enrolled or planning to participate in a concurrent drug and/or device
             study during the course of this study that would confound study results as determined
             by the study physician

          -  Subject is unwillingly to comply with the randomization procedure

          -  Subject has had no syncopal episodes in last six months while on medical therapy

          -  Subject has one of the following conditions that is the documented source of syncope:
             sick sinus syndrome, sinus node or atrioventricular conduction deficiencies,
             ventricular tachyarrhythmias, pulmonary hypertension, hypertrophic cardiomyopathy,
             history of transient ischemic attack, seizure disorders, subclavian steal syndrome, or
             drug-induced syncope

          -  Subjects with a myocardial infarction within last six months

          -  Subjects with severe heart failure (NYHA class III or IV), previous heart surgery,
             structural heart disease, or an infiltrative cardiac disease

          -  Subject is contraindicated for left-atrial ablation, as determined by enrolling
             physician
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Contradiction