Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

Universitätsklinikum Hamburg-Eppendorf102 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Paroxysmal Atrial Fibrillation Catheter Ablation Strategies

Interventions

catheter based pulmonary vein isolationDEVICE

catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Hamburg

Hamburg, Germany

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

procedure duration

time needed to complete the procedure

Time frame: completed (15 months)

procedure safety

complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed

Time frame: up to three days after the procedure

Data from ClinicalTrials.gov

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