PulseSelect™ PFA Global Registry

Medtronic Cardiac Ablation Solutions1,950 enrolled

Overview

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Study Type

OBSERVATIONAL

Enrollment

1,950

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is ≥ 18 years of age or minimum age as required by local regulations. * Subject has been diagnosed with atrial fibrillation (AF) * 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.

Locations (43)

Outcomes

Primary Outcomes

Efficacy-Freedom from Atrial Fibrillation

Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.

Time frame: ≥ 91 days after the index ablation procedure

Safety- Freedom from Device/Procedure Related Adverse Events

Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system

Time frame: Within 6 months post-ablation

Central Contacts

Josman Suri

CONTACT

7635050262 josman.suri@medtronic.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Jessa Ziekenhuis

Hasselt, Belgium

ACTIVE_NOT_RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, Canada

ACTIVE_NOT_RECRUITING

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

ACTIVE_NOT_RECRUITING

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

RECRUITING

The First Peoples Hospital of Yunnan Province

Kunming, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, China

RECRUITING

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

ACTIVE_NOT_RECRUITING

Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences

Shenzhen, China

RECRUITING

...and 33 more locations