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NCT06393920 Clinical Trial

PulseSelect PFA Global Registry

Atrial Fibrillation Clinical Trial

Official title:
PulseSelect PFA Global Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06393920
Other study ID # PulseSelect PFA Registry
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date October 1, 2029

Study information
Verified date May 2024
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

PulsedSelect is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Description:

PulsedSelect is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 6, 12, 24, and 36 months, including required 24-hour Holter monitoring at each visit. The PulseSelect™ PFA System-System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date October 1, 2029
Est. primary completion date October 1, 2028
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject is = 18 years of age or minimum age as required by local regulations. - Planned procedure using commercially available PulseSelect™ PFA System. - Willing to comply with study requirements and give informed consent (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: - Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager. - Subject with exclusion criteria required by local law.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Outcome
Type Measure Description Time frame Safety issue
Primary Freedom from Atrial Fibrillation Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA System. 36 Months Post Proceedure
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