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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Adenosine

Isoproterenol

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, ablation, adenosine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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)

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Adenosine and Isoproterenol

Isoproterenol

Arm Description

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

This group will not receive adenosine during the procedure.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Subjects Who Need Repeat Ablations

Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.

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

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

Prevalence of recovery of conduction into pulmonary veins during repeat ablation procedures in both groups. This is determined by surgeon assessment using a circular mapping catheter to identify recovery of conduction into the pulmonary veins.

Incidence of Stroke

Number of subjects who develop stroke within 30 days after procedure.

Incidence of Pulmonary Vein Stenosis

Number of subjects who develop Symptomatic pulmonary vein stenosis

Incidence of Cardiac Perforation

Number of subjects who develop perforation of heart during ablation

Incidence of Atrio-esophageal Fistula

Number of subjects who develop connection between heart and the esophagus

Incidence of Death

Number of deaths within 90 days of the procedure.

Full Information

NCT ID

NCT03032965

First Posted

September 1, 2016

Last Updated

November 15, 2017

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03032965

Brief Title

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

Official Title

Adenosine Study in Paroxysmal Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Hypothesis: Adenosine reveals incomplete conduction block due to partial tissue injury/stunning during catheter ablation of atrial fibrillation. Identification of incomplete conduction block by adenosine improves clinical outcomes including an increase in efficacy and a decrease in need for repeat procedures after catheter ablation of atrial fibrillation. Objectives: In patients with paroxysmal Atrial Fibrillation (AF), the prevalence of Pulmonary Vein (PV) reconnection during adenosine infusion after complete PV isolation using conventional techniques will be determined. Patients will be randomized to further ablation to achieve complete isolation during adenosine infusion vs to no further ablation. Primary endpoint of the study will be freedom from any atrial arrhythmias 6 months after a single ablation procedure in the absence of antiarrhythmic drug therapy. Secondary endpoints will include number of repeat ablation procedures because of documented recurrence of symptomatic AF or atrial flutter/tachycardia, outcome after 2 ablation procedures; Proportion of patients with AF or atrial flutter/tachycardia occuring during the first three months post ablation, prevalence of recovery of conduction into PVs during repeat ablation procedures in both groups, procedure duration, and incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, atrio-esophageal fistulae, and death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

atrial fibrillation, ablation, adenosine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adenosine and Isoproterenol

Arm Type

Experimental

Arm Description

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

Arm Title

Isoproterenol

Arm Type

Other

Arm Description

This group will not receive adenosine during the procedure.

Intervention Type

Drug

Intervention Name(s)

Adenosine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Isoproterenol

Other Intervention Name(s)

Isuprel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Freedom From Any Atrial Arrhythmias

Description

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

Time Frame

2- 14 months after Ablation procedure

Secondary Outcome Measure Information:

Title

Number of Subjects Who Need Repeat Ablations

Description

Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.

Time Frame

date of ablation to 6 months after procedure

Title

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

Time Frame

first three months post ablation

Title

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

Description

Time Frame

post-procedure (6 months)

Title

Incidence of Stroke

Description

Number of subjects who develop stroke within 30 days after procedure.

Time Frame

peri-procedural (0 to 30 days after procedure)

Title

Incidence of Pulmonary Vein Stenosis

Description

Number of subjects who develop Symptomatic pulmonary vein stenosis

Time Frame

6 months post-procedure

Title

Incidence of Cardiac Perforation

Description

Number of subjects who develop perforation of heart during ablation

Time Frame

within 24 hours

Title

Incidence of Atrio-esophageal Fistula

Description

Number of subjects who develop connection between heart and the esophagus

Time Frame

within 4 weeks

Title

Incidence of Death

Description

Number of deaths within 90 days of the procedure.

Time Frame

with 90 days of the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Ghanbari, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

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

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