Atrial FibrillationPhase 2NCT03032965
Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
A Phase 2 study testing Adenosine and Isoproterenol in people with Atrial Fibrillation, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Adenosine and Isoproterenol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adenosine Study in Paroxysmal Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Adenosine, Isoproterenol
- Keywords
- atrial fibrillation, ablation, adenosine
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called Isuprel
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.
| Study group | Role | What they receive |
|---|---|---|
| Adenosine and Isoproterenol | Experimental | Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction. Receives: Drug: Adenosine; Drug: Isoproterenol |
| Isoproterenol | Other | This group will not receive adenosine during the procedure. Receives: Drug: Isoproterenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2- 14 months after Ablation procedure
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: post-procedure (6 months)
Incidence of Stroke
Number of subjects who develop stroke within 30 days after procedure.
Measured: peri-procedural (0 to 30 days after procedure)
Incidence of Pulmonary Vein Stenosis
Number of subjects who develop Symptomatic pulmonary vein stenosis
Measured: 6 months post-procedure
Incidence of Cardiac Perforation
Number of subjects who develop perforation of heart during ablation
Measured: within 24 hours
Incidence of Atrio-esophageal Fistula
Number of subjects who develop connection between heart and the esophagus
Measured: within 4 weeks
Incidence of Death
Number of deaths within 90 days of the procedure.
Measured: with 90 days of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startOct 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Ghanbari, University of Michigan
- Investigators
- Hamid Ghanbari, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032965
- Sponsor's protocol ID
- HUM00048922
- Status last verified
- Nov 2017
- First submitted
- 1 Sep 2016
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine Study in Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03032965
- Acronym / sponsor ID
- HUM00048922
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation, adenosine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenosine and Isoproterenol | Experimental | Drug: Adenosine, Drug: IsoproterenolPatients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction. |
| Isoproterenol | Other | Drug: IsoproterenolThis group will not receive adenosine during the procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenosineSubject 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. | Drug | Adenosine and Isoproterenol |
| IsoproterenolAlso: IsuprelIsoproterenol 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. | Drug | Adenosine and Isoproterenol, Isoproterenol |
Primary outcome
Freedom From Any Atrial Arrhythmias
Time frame: 2- 14 months after Ablation procedure
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
8 secondary outcomes
Number of Subjects Who Need Repeat Ablations
Time frame: 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
Time frame: first three months post ablation
Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups
Time frame: post-procedure (6 months)
Incidence of Stroke
Time frame: peri-procedural (0 to 30 days after procedure)
Incidence of Pulmonary Vein Stenosis
Time frame: 6 months post-procedure
Incidence of Cardiac Perforation
Time frame: within 24 hours
Incidence of Atrio-esophageal Fistula
Time frame: within 4 weeks
Incidence of Death
Time frame: with 90 days of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Ghanbari, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adenosine and Isoproterenol in people with Atrial Fibrillation, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Any Atrial Arrhythmias (time frame: 2- 14 months after Ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.