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COMPLETED
NCT03811795
NA

Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib

Sponsor: Valley Health System

View on ClinicalTrials.gov

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 ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation.

Official title: Cryoballoon vs. Rhythmia Guided Ablation for Recurrent Atrial Fibrillation Following Initial Cryoballoon Pulmonary Vein Isolation

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2018-11-27

Completion Date

2022-04-26

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

OTHER

ECG monitoring with a Kardia Mobile monitor

The participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians.

Locations (3)

Iowa Heart Center

West Des Moines, Iowa, United States

The Valley Hospital

Paramus, New Jersey, United States

Peace Health

Springfield, Oregon, United States