Catheter Ablation of Drug-refractory Persistent Atrial NCT01863472

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01863472
Other study ID #	FF20/13 Version 03
Secondary ID
Status	Completed
Phase	N/A
First received	May 19, 2013
Last updated	November 18, 2016
Start date	June 2013
Est. completion date	November 2016

Study information
Verified date	November 2016
Source	Cardioangiologisches Centrum Bethanien
Contact	n/a
Is FDA regulated	No
Health authority	Germany: Ethics Commission
Study type	Interventional

Clinical Trial Summary

Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.

Recruitment information / eligibility
Status	Completed
Enrollment	152
Est. completion date	November 2016
Est. primary completion date	September 2016
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years to 80 Years
Eligibility	Inclusion Criteria: - 18 to 80 years - persistent atrial fibrillation - failure of at least one antiarrhythmic drug - others Exclusion Criteria: - contraindications for pulmonary vein isolation (PVI) - previous PVI attempts - inability to be treated with oral anticoagulation - presence of intracardiac thrombi - pregnancy - others

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• HeartLight(TM) Laser Balloon
With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
• irrigated radiofrequency current ablation
The irrigated radiofrequency current ablation is used for pulmonary vein isolation

Locations
Country	Name	City	State
Czech Republic	Na Homolce Hospital	Prague
Germany	Herz- und Gefäß-Klinik GmbH Bad Neustadt	Bad Neustadt	Bavaria
Germany	Rheinische Friedrich-Wilhelms-Universität Bonn	Bonn	NRW
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt/Main
Germany	Städtisches Klinikum Karlsruhe, Medizinische Klinik IV	Karlsruhe
Spain	Hospital Universitari i Politecnic La Fe	Valencia

Sponsors *(1)*
Lead Sponsor	Collaborator
Boris Schmidt

Countries where clinical trial is conducted

Czech Republic, Germany, Spain,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds		between day 90 and 365 days after index procedure	No

See also
Status	Clinical Trial	Phase
Completed	`NCT05970120` - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter	N/A
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT03650556` - Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation	N/A
Recruiting	`NCT04085731` - Driver-guided Ablation of Persistent Atrial Fibrillatiom
Withdrawn	`NCT02344394` - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation	N/A
Terminated	`NCT01683045` - Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats	N/A
Completed	`NCT01694563` - ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation	N/A
Active, not recruiting	`NCT03643224` - DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation	N/A
Withdrawn	`NCT05093868` - Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF)	N/A
Completed	`NCT05152966` - Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)	N/A
Completed	`NCT05043883` - Automated Assessment of PVI Using a Novel EP Recording System	N/A
Completed	`NCT04022954` - HD Mapping of Atrial Fibrillation in Asia Pacific
Active, not recruiting	`NCT06124690` - Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas	N/A
Not yet recruiting	`NCT05454111` - CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation	N/A
Completed	`NCT06260670` - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation	N/A
Active, not recruiting	`NCT05077670` - Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
Withdrawn	`NCT03835338` - WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm	N/A
Completed	`NCT02275104` - Multimodal Image Processing Software to Guide Cardiac Ablation Therapy	N/A
Not yet recruiting	`NCT05565183` - Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.	N/A
Completed	`NCT02274857` - Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures	N/A

Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Countries where clinical trial is conducted

Outcome