Status:
UNKNOWN
Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
Lead Sponsor:
Valley Health System
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform repeat ablatio...
Detailed Description
The study is a randomized, prospective multicenter pilot study to assess the utility and efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in subjects with rec...
Eligibility Criteria
Inclusion
- Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per recent HRS guidelines and standard practice;
- Individuals in whom the initial ablation approach was cryoballoon PVI at the enrolling institution more than 3 month or more prior to the anticipated repeat ablation;
- Age ≥ 18 years.
Exclusion
- Individuals with recurrent AF who previously underwent RF-based PVI;
- Individuals with known contraindications to ablation including permanent atrial fibrillation or intolerance of anticoagulation;
- Individuals unable or not willing to complete follow-up visits and examination for the duration of the study;
- Individuals without access to smartphone or tablet compatible with the monitoring system;
- Prior valve surgery or surgical AF ablation;
- Individuals with mental or physical limitations precluding informed consent;
- Individuals currently enrolled in another investigational study or registry;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03811795
Start Date
November 27 2018
End Date
November 1 2023
Last Update
March 30 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
2
The Valley Hospital
Paramus, New Jersey, United States, 07652
3
Peace Health
Springfield, Oregon, United States, 97477