Clinical Trials Logo

Clinical Trial Summary

A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.


Clinical Trial Description

The telemetric smartphone application includes a digitized medical record, a mobile ECG device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care cost calculations and recurrences of atrial fibrillation after ablation. All patients will undergo ablation and will be randomized into two groups: 1) conventional follow up with outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with the smartphone application, a mobile ECG device (patients will be able to send in as many ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as well as outpatient visits 6 and 12 months after cryo-ablation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03268707
Study type Interventional
Source Universitätsklinikum Hamburg-Eppendorf
Contact Melanie Gunawardene, MD
Phone 004940741054120
Email m.gunawardene@uke.de
Status Recruiting
Phase N/A
Start date July 15, 2017
Completion date June 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Completed NCT03624881 - Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU) Phase 4
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Recruiting NCT05905835 - Treatment of PAF With the Synaptic System N/A
Active, not recruiting NCT05534581 - SINGLE SHOT CHAMPION Phase 4
Active, not recruiting NCT05618340 - PFA for Paroxysmal Atrial Fibrillation N/A
Not yet recruiting NCT05024630 - Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension N/A
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Completed NCT01913522 - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration N/A
Withdrawn NCT01917981 - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation Phase 3
Terminated NCT01925885 - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) N/A
Completed NCT01693107 - Atrial Fibrillation Force Contact Ablation Study
Completed NCT01842529 - Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery Phase 2
Completed NCT00971204 - Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation Phase 2
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Recruiting NCT05172765 - Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF) N/A
Recruiting NCT04529785 - Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific
Completed NCT00964392 - NAVISTAR® THERMOCOOL® Catheter Post Approval Registry Phase 4