CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Adenosine +1 moredrug
Likely dose
Adenosine 24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03032965
NCT03032965Phase 2Completed

Adenosine Study in Paroxysmal Atrial Fibrillation

University of Michigan·interventional·Posted Jan 26, 2017·Updated Dec 13, 2017

In Brief

A Phase 2 clinical trial evaluating Adenosine and Isoproterenol for Atrial Fibrillation. Completed, enrolled 131 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2017
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.4 years ago

Interventions

Adenosinedrug

Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction. Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.

Isoproterenoldrug

Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to\<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.