Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 13, 2017
Trial Information
Current as of May 07, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • (Step 1 - Registration)
- • The subject is 18 years of age or older
- • Left atrium \< 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
- • performed within 6 months)
- • Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
- • Provided written informed consent
- • Be eligible for an AF ablation procedure for Paroxysmal AF
- • (Step 2 - Randomization)
- • Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation
- Exclusion Criteria:
- • (Step 1 - Registration)
- • Pregnant or planning to become pregnant during study
- • Co-morbid medical conditions that limit one-year life expectancy
- • Previous cardiac surgery
- • Patients who have active infection or sepsis
- • Patients with esophageal ulcers strictures and varices
- • Patients who are contraindicated for anticoagulants such as heparin and warfarin
- • Patients who are being treated for ventricular arrhythmias
- • Patients who have had a previous left atrial catheter ablation for AF (does not
- • include ablation for AFL or other supraventricular arrhythmias)
- • Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
- • Not competent to legally represent him or herself (e.g., requires a guardian or
- • caretaker as a legal representative)
- • (Step 2 Randomization)
- • Not able to receive additional linear or focal intracardiac catheter ablation
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milwaukee, Wisconsin, United States
Patients applied
Trial Officials
Jasbir Sra, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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