CTRI/2022/02/040484
Active, not recruiting
Phase 4
To Treat Cardiac Arrhythmias Patients with Cardiac Cryoablation Catheters in India- Cryo Global Registry study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: I480- Paroxysmal atrial fibrillation
- Sponsor
- India Medtronic Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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