An Exploratory Safety and Efficacy Clinical Study of CARDIX-101 for the Treatment of Chronic Bradycardia

This is an interventional treatment trial for Bradycardia Read More

Inclusion Criteria:

1. The subject has bradycardia (H.R. <60 BPM). The subject's symptoms, if any, such as dizziness, confusion, fatigue, shortness of breath, chest pain, and syncope, are required to be documented in the case report form (CRF) in the screening, treatment, and follow-up periods.
2. The subject has been informed of the investigational nature of this study and has completed a written informed consent form (ICF) in accordance with institutional, local, and national guidelines.
3. The subject is able to return for the safety and efficacy follow up period and provides at least two modes of contact information (e.g., home and mobile phone numbers, address) and contact information for at least one close contact (e.g., family member or friend) to facilitate follow up.
4. The subject is a male or female 18-80 years of age.

Exclusion Criteria:

1. Patients with peptic ulcer disease, seizure disorder, or cardiac arrhythmia with tachycardia are excluded
2. Patients with asthma who are already taking a beta-agonist and/or Theophylline are excluded
3. Pregnancy (all women of childbearing potential, unless surgically sterilized or post-menopausal defined as the cessation of menses for over one year, receive a pregnancy test).
4. Systolic blood pressure is <100 mmHg.
5. Heart rate >60 bpm.
6. Severe bradycardia or sinus pauses, which in the opinion of the P.I. requires urgent pacemaker implantation or A.V. block > 2nd degree, or existing implanted pacemaker.
7. Serum potassium <4.0 mEq/L or mmol/L by the local laboratory at the screening.
8. History of receiving another Class I or Class III antiarrhythmic drug within three days prior to enrollment. Excluded Class I antiarrhythmic drugs include quinidine, procainamide, disopyramide, lignocaine, mexiletine, flecainide, and propafenone. Excluded Class III drugs include dofetilide, sotalol, dronedarone, and ranolazine.
9. There is a history of amiodarone (oral or IV) within 90 days prior to the study.
10. There is native or prosthetic aortic or mitral stenosis with aortic valve area ≤1.0 cm2, or mitral valve area of <1.5 cm2 or any other valvular diseases requiring surgery.
11. There is an ejection fraction of <35% within one year prior to enrollment (most recent measure if more than one).
12. Atrial fibrillation (A.F.) or atrial flutter (AFL) as a result of surgery (postoperative AF/AFL) within 30 days prior to the study.
13. There is a history of electrical cardioversion within seven calendar days prior to the study.
14. There is a history of any polymorphic ventricular tachycardia, including torsade de points.
15. History or family history of long Q.T. syndrome or other inherited arrhythmia syndrome.
16. There is a history of ventricular tachycardia requiring drug or device therapy.
17. Participation in another investigational drug or device trial within 30 days prior to the study. (subjects in registries may participate with the approval of the registry sponsor.)
18. Acute cardiovascular events (myocardial infarction, pulmonary embolism, cerebrovascular accident, unstable angina, or transient ischemic attack) within 90 days prior to enrollment.
19. Psychiatric disorder, active alcohol/drug abuse, or other circumstance or condition that, in the Investigator's opinion, may interfere with any aspect of protocol adherence or a subject's ability to give informed consent.
20. Untreated hyperthyroidism or hypothyroidism.
21. Acute pericarditis.
22. Unrelated illness such as substantial infection, fever, or prescribed antibiotics in the last seven days, acute rheumatic fever, metastatic cancer, severe hepatic disease, or other extreme medical conditions
23. Exclusion of a woman who is breastfeeding.