Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/8/2017 |
| Start Date: | May 2012 |
| End Date: | June 2015 |
Validation of the Durability of the Adenosine Effect in Verification of Pulmonary Vein Isolation
Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins
during atrial fibrillation ablation, however, the methodology has not been validated either
in terms of the reproducibility of the adenosine response or the effect on clinical outcomes,
namely whether using pulmonary vein reconnection to guide additional ablation lowers rate
recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response
to adenosine used in this manner is reproducible over time.
during atrial fibrillation ablation, however, the methodology has not been validated either
in terms of the reproducibility of the adenosine response or the effect on clinical outcomes,
namely whether using pulmonary vein reconnection to guide additional ablation lowers rate
recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response
to adenosine used in this manner is reproducible over time.
Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be
randomized to treatment and control groups. Treatment group subjects will received 12 mg IV
adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is
documented. If electrical reconnection is not observed at 5 minutes, a second dose of
adenosine will be administered, monitoring again for electrical reconnection. Control
patients will be observed for 10 minutes post initial electrical isolation of the pulmonary
vein for spontaneous electrical reconnection. If reconnection is observed, veins will be
re-isolated per standard clinical practice. This procedure will be repeated for each of a
patient's pulmonary veins. Patients will be followed up at clinical visits to examine for
adverse effects of procedure and/or adenosine administration as well as atrial fibrillation
recurrence.
randomized to treatment and control groups. Treatment group subjects will received 12 mg IV
adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is
documented. If electrical reconnection is not observed at 5 minutes, a second dose of
adenosine will be administered, monitoring again for electrical reconnection. Control
patients will be observed for 10 minutes post initial electrical isolation of the pulmonary
vein for spontaneous electrical reconnection. If reconnection is observed, veins will be
re-isolated per standard clinical practice. This procedure will be repeated for each of a
patient's pulmonary veins. Patients will be followed up at clinical visits to examine for
adverse effects of procedure and/or adenosine administration as well as atrial fibrillation
recurrence.
Inclusion Criteria:
- Patients undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter
for standard clinical indications
Exclusion Criteria:
- allergy or contraindication to adenosine,
- inability to give informed consent,
- currently taking dipyridamole,
- verapamil or theophylline and
- breast-feeding mothers.
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