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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
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