Catheter Ablation Strategies, Paroxysmal Atrial Fibrillation
Conditions
Brief summary
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
Detailed 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.
Interventions
DEVICEcatheter based pulmonary vein isolation
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to AF and AT recurrence | 12 months | recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure duration | completed (15 months) | time needed to complete the procedure |
| procedure safety | up to three days after the procedure | complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed |
Countries
Germany
Outcome results
None listed