Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation

NCT03032965 | Completed Phase 2 Results

• 1 other identifier: HUM00048922
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; ablation; adenosine

Outcome Measures

Primary Outcomes (1)

• Freedom From Any Atrial Arrhythmias

  Primary endpoint of the study will be number of participants who are free from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy

  2- 14 months after Ablation procedure

Secondary Outcomes (8)

• Number of Subjects Who Need Repeat Ablations

  date of ablation to 6 months after procedure

• Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation

  first three months post ablation

• Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups

  post-procedure (6 months)

• Incidence of Stroke

  peri-procedural (0 to 30 days after procedure)

• Incidence of Pulmonary Vein Stenosis

  6 months post-procedure

Study Arms (2)

Adenosine and Isoproterenol

EXPERIMENTAL

Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.

Drug: Adenosine; Drug: Isoproterenol

Isoproterenol

OTHER

This group will not receive adenosine during the procedure.

Drug: Isoproterenol

Interventions

Adenosine DRUG

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.

Adenosine and Isoproterenol

Isoproterenol DRUG

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.

Also known as: Isuprel

Adenosine and Isoproterenol; Isoproterenol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 and \<75 who are able to give informed consent undergoing atrial fibrillation ablation procedure.
• Paroxysmal Atrial fibrillation lasting = 7 days which is self-terminating. It is considered recurrent if two or more episodes occur.
• Failure or unwilling to take class I or III anti-arrhythmic drugs

You may not qualify if:

• History of asthma
• Patients with severe coronary artery disease, stable/unstable angina, or ongoing myocardial ischemia
• Previous cardiac surgery ( excluding CABG and mitral valve surgery)
• Symptomatic congestive heart failure including but not limited to NYHA III/IV and/or documented ejection fraction \<40% measured by acceptable cardiac testing,
• Left atrial diameter \>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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Adenosine; Isoproterenol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Hamid Ghanbari
• Organization: University of Michigan

ghhamid@med.umich.edu

734-963-7141

Study Officials

• Hamid Ghanbari, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: January 26, 2017
• Study Start: October 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-11

Locations

US (1)