Medtronic Cardiac Ablation (Freezes the Heart Tissue to help break electrical signals) Post-Market Study platform which looks at real-world ? product safety and patient clinical outcomes.
- Conditions
- Health Condition 1: I480- Paroxysmal atrial fibrillation
- Registration Number
- CTRI/2022/02/040484
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Subject is = 18 years of age or minimum age as required by local regulations
2. Planned procedure using commercially available Arctic Front™ and Freezor™ Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System)
3. Willing to comply with study requirements and give informed consent (IC) (defined as legally effective, documented confirmation of a subject’s voluntary agreement to participate in
this clinical study) or authorization per institution and geographical requirements
1. Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
2. Subject with exclusion criteria required by local law
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Freedom from atrial fibrillation (AF) <br/ ><br>recurrence using the Arctic Front™ Family of Cardiac Cryoablation Catheters <br/ ><br>2.Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT) recurrence using the Arctic Front™ Family of Cardiac Cryoablation Catheters <br/ ><br>3.Freedom from arrhythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters <br/ ><br>4. Device and procedure related adverse events for <br/ ><br>cryoablation using the Arctic Front™ Cardiac Cryoablation <br/ ><br>Catheter SystemTimepoint: 1 Year
- Secondary Outcome Measures
Name Time Method 1. Characteristics of the cryoablation procedure <br/ ><br>2. Change in quality of life (QoL) <br/ ><br>3. Characteristics of global Standard of Care (SOC) for ablation patients receiving a cryoablation <br/ ><br>4. All cause, cardiovascular, and arrhythmia related <br/ ><br>rehospitalization rates post-ablationTimepoint: 1 Year