Clinical trial: Safety and Performance Study of the Moderato System (NCT02282033)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is ≥ 18 years of age

          -  Subject is indicated for implantation or replacement of a dual chamber permanent
             pacemaker where no lead extraction is necessary.

          -  Subject has stable regimen of 2 or more maximally tolerated anti-hypertension
             medications, which is anticipated to be able to be maintained without changes for 3
             months.

          -  Subject has office systolic blood pressure measurements > 140 mmHg on two separate
             days within a one week period prior to enrollment, and the average of these two
             measurements is ≥150 mmHg

        Exclusion Criteria:

          -  Subject has known secondary cause of HTN

          -  Subject has a history of atrial fibrillation

          -  Subject has ejection fraction <50%

          -  Subject has symptoms of heart failure of NYHA Class II or more

          -  Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or
             interventricular septal thickness ≥15 mm

          -  Subject is on dialysis

          -  Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2

          -  Subject has prior neurological events (stroke or TIA) or carotid artery disease

          -  Subject has known autonomic dysfunction

          -  Subject has a history of clinically significant tachyarrhythmia

          -  Subject has had previous active device-based treatment for hypertension

          -  Subject has an existing implant, other than a pacemaker that needs replacing

          -  Subject with average Systolic BP >190 mmHg
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