N/A
Completed N=20
Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation
Source: ClinicalTrials.gov NCT01590875 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Pulmonary Vein Reconnection — 10; 10 Participants — p=<0.01
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Vein Reconnection |
3; 0; 7; 10 | < 0.01 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01590875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.