Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
Completed · Not applicable
Conditions studied: Atrial Fibrillation
In brief
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 ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation.
Key facts
- Study ID
- NCT03811795
- Run by
- Valley Health System
- People needed
- 9
- Starts
- 2018-11-27
- Expected to finish
- 2022-04-26
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Iowa Heart Center — West Des Moines, Iowa, United States
- The Valley Hospital — Paramus, New Jersey, United States
- Peace Health — Springfield, Oregon, United States
Full record on ClinicalTrials.gov
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