ANOSTIM SAFETY AND PERFORMANCE TRIAL FOR A LEADLESS CARDIAC PACEMAKER SYSTEM

Completed

• Conditions: cardiac arrhythmia; irregular heartbeat; 10007521

• Registration Number: NL-OMON36843
• Lead Sponsor: anostim, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Subject must have one of the following clinical indications:
* Chronic atrial fibrillation1 with 2 or 3° AV or bifascicular bundle branch block (BBB block)2; or
* Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
* Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and ;2. Subject *18 years of age; and
3. Subject has life expectancy of at least one year; and
4. Subject is not enrolled in another clinical investigation; and
5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; and
7. If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.

Exclusion Criteria

1. Pacemaker dependent; or
2. Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or
3. Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; or
4. Mechanical tricuspid valve prosthesis; or
5. Pre-existing pulmonary arterial (PA) hypertension3 or significant physiologically-
impairing lung disease; or
6. Pre-existing pacing or defibrillation leads; or
7. Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
8. Presence of implanted vena cava filter; or
9. Presence of implanted leadless cardiac pacemaker; or
10. Pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety endpoint is to evaluate a 90-day complication rate, where a<br /><br>complication is defined as a serious adverse device effect (SADE)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To report pacing, sensing, and rate-response performance, implant success rate,<br /><br>and safety analysis with reporting of all adverse events.</p><br>