Clinical trial: Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY (NCT01614717)

Eligibility criteria:
Inclusion Criteria:

          1. Unequivocal diagnosis of hypertrophic cardiomyopathy (HCM), on the basis of
             2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness ≥15
             mm) and nondilated Left Ventricle (Left Ventricle End Diastolic Diameter (LVEDD) <
             55mm) confirmed by a Core Lab Echo (Appendix I).

          2. Significant resting (not provoked) LV outflow tract obstruction, on the basis of peak
             LVOT gradient ≥50 mmHg, estimated by continuous wave Doppler and confirmed by a Core
             Lab Echo (Appendix I).

          3. Presence of refractory symptoms (exertional dyspnea or chest pain) despite of optimal
             treatment with betablockers and/or verapamil for at least 3 months (NYHA class >II).

          4. Patients that refuse or have contraindication for septal myectomy or septal ablation
             (i.e., comorbidity, inappropriate coronary anatomy for septal ablation), that prefer
             cardiac pacing, or that are at high risk for developing heart block following septal
             myectomy or septal ablation.

        6. Patient's age is 18 years or greater. 7. Patients must indicate their understanding of
        the study and willingness to participate by signing the appropriate informed consent form.

        8. Patients must be willing and able to comply with all study requirements.

        Exclusion Criteria:

          1. Known causes of cardiac hypertrophy as infiltrative cardiomyopathy, aortic stenosis
             and severe uncontrolled hypertension.

          2. Permanent or persistent atrial fibrillation.

          3. Previous septal myectomy or septal ablation.

          4. Any indication for permanent pacing, except for HOCM.

          5. Any indication for an Implantable Cardioverter Defibrillator (ICD).

          6. Systemic disease that would preclude completion of the protocol.

          7. Any disability or limitations to correctly understand or complete the study (physical,
             intellectual, logistical).

          8. Patients with a life expectancy <24 months (based on investigator assessment).

          9. Patients who are or may potentially be pregnant.
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? Entailment