To collect data of devices used during your ablation procedure

Recruiting

• Conditions: Other specified cardiac arrhythmias,

• Registration Number: CTRI/2022/08/044935
• Lead Sponsor: Abbott India Pvt Ltd

Brief Summary

Thepurpose of this registry is to collect medical information and experiences withdevices used during routine electrophysiology procedure. The registry will enroll 7,500 subjects across 20 or moresitesworldwide. Enrolled subject will be followed for 1year . This information will be used to confirm the safety, performance, and clinical benefits of these devices.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-09
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

• Subject underwent an electrophysiology imaging (diagnostic procedure) and/or ablation procedure that used one or more Abbott devices covered by this Registry.
• Subject is willing and able to comply with the site’s standard of care follow-up schedule.

Exclusion Criteria

Subject is currently participating in another clinical investigation that may confound the results of this Registry.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a device- and/or procedure-related Serious Adverse Event	Reported within 7-days of the procedure

Secondary Outcome Measures

Name	Time	Method
The proportion of procedures that achieved acute success.	Baseline

Trial Locations

Locations (2)

Max Super Specialty Hospital; 🇮🇳 Delhi, DELHI, India

Sree Chitra TirunalInstitute for MedicalSciences & Technology; 🇮🇳 Thiruvananthapuram, KERALA, India

Max Super Specialty Hospital

🇮🇳Delhi, DELHI, India

Dr Balbir Singh

Principal investigator

9810842890

drbalbirs@gmail.com