Phase 2
N=129
Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03032965 ↗Enrolled (actual)
129
Serious AEs
5.4%
Results posted
Dec 2017
Primary outcome: Primary: Freedom From Any Atrial Arrhythmias — 24; 23 Participants — p=.83
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adenosine (Drug); Isoproterenol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Any Atrial Arrhythmias |
24; 23 | .83 |
| SECONDARY Number of Subjects Who Need Repeat Ablations |
12; 9 | .35 |
| SECONDARY Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation |
— | — |
| SECONDARY Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups |
29; 28 | 0.09 |
| SECONDARY Incidence of Stroke |
0; 0 | — |
| SECONDARY Incidence of Pulmonary Vein Stenosis |
0; 0 | — |
| SECONDARY Incidence of Cardiac Perforation |
0; 0 | — |
| SECONDARY Incidence of Atrio-esophageal Fistula |
0; 0 | — |
| SECONDARY Incidence of Death |
0; 0 | — |
Summary
The purpose of this study is to determine if additional ablation during the first procedure as the result of the ability to medically induce quiet atrial arrhythmias will improve clinical outcome in patients with atrial fibrillation thus decreasing the need for additional ablation procedures.
Eligibility Criteria
Inclusion Criteria
- Patients >18 and 55mm
- Moderate to severe mitral or aortic valve disease
- Myocardial infarction within three months of enrollment
- Congenital heart disease where it increases the risk of an ablative procedure
- Prior ASD/PFO closure with a device using a percutaneous approach
- Hypertrophic cardiomyopathy (LV wall thickness >1.5mm)
- Pulmonary Hypertension (mean or systolic PA pressure> 50mmHg on Doppler echocardiography
- Any prior ablation of atrial fibrillation
- Enrollment in any other arrhythmia protocol
- Any ventricular arrhythmia being treated where the arrhythmia or management may interfere with this study
- Active infection or sepsis
- Any history of cerebrovascular disease including stroke or TIAs
- Pregnancy or lactation
- Left atrial thrombus at the time of ablation
- Untreatable allergy to contrast media
- Any diagnosis of atrial fibrillation secondary to electrolyte disturbance, thyroid disease, or any other reversible or non-cardiovascular causes
- History of blood clotting(bleeding or thrombotic) abnormalities
- Known sensitivities to heparin or warfarin
- Severe COPD (defined as FEV1 <1)
- Severe comorbidity or poor general physical/mental health that, in opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy)
Data sourced from ClinicalTrials.gov (NCT03032965). 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.