Clinical Trials Logo
  1. Home
  2. Paroxysmal Atrial Fibrillation
  3. NCT01724437
  4. Details
NCT01724437 Clinical Trial

Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01724437
Other study ID # PV3503
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date November 2012

Study information
Verified date August 2022
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to assess the near-term (12 months) efficacy of pulmonary vein isolation.

Description:

The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date November 2012
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - written informed consent - age > 18 years - paroxysmal atrial fibrillation Exclusion Criteria: - structural heart disease - intracardiac thrombus - reversible causes of atrial fibrillation - inability to take warfarin

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• catheter based pulmonary vein isolation
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice

Locations
Country Name City State
Germany University Hospital Hamburg Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to AF and AT recurrence recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring 12 months
Secondary procedure duration time needed to complete the procedure completed (15 months)
Secondary procedure safety complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed up to three days after the procedure
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 NCT05618340 - PFA for Paroxysmal Atrial Fibrillation N/A
Active, not recruiting NCT05534581 - SINGLE SHOT CHAMPION Phase 4
Not yet recruiting NCT05024630 - Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension N/A
Completed NCT01913522 - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration N/A
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Terminated NCT01925885 - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) N/A
Withdrawn NCT01917981 - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation Phase 3
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

External Links