Atrial FibrillationNCT01590875
Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation
A study testing Adenosine arm in people with Atrial Fibrillation, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein… 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 arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2015
- Phase
- Interventional
- 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 undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter for standard clinical indications
Who cannot join
- allergy or contraindication to adenosine,
- inability to give informed consent,
- currently taking dipyridamole,
- verapamil or theophylline and
- breast-feeding mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Durability of the Adenosine Effect in Verification of Pulmonary Vein Isolation
Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.
Read the detailed description
Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. Treatment group subjects will received 12 mg IV adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. If electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. Control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. If reconnection is observed, veins will be re-isolated per standard clinical practice. This procedure will be repeated for each of a patient's pulmonary veins. Patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence.
- Conditions
- Atrial Fibrillation
- Being tested
- Adenosine arm
- Keywords
- atrial fibrillation, ablation, pulmonary veins, 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.
Adenosine armDrug
In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.
| Study group | Role | What they receive |
|---|---|---|
| Adenosine arm | Experimental | 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. Receives: Drug: Adenosine arm |
| Observation arm | No intervention | 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Vein Reconnection
In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes after adenosine administration.
Measured: 5 minutes post infusion first dose adenosine
Pulmonary Vein Reconnection
In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection. Criteria for pulmonary vein reconnection will be recurrence of local pulmonary vein electrical recordings noted on lasso catheter located within the vein. Pulmonary vein isolation is defined as disappearance of all local intracardiac electrograms within a pulmonary vein recorded on a 10 electrode circular catheter or lasso catheter positioned within the vein.
Measured: Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2015
- Study completionJun 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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcie G. Berger, MD, Medical College of Wisconsin
- Investigators
- Marcie G Berger, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590875
- Sponsor's protocol ID
- MCWPRO00016186
- Status last verified
- Oct 2017
- First submitted
- 30 Apr 2012
- Last updated
- 6 Nov 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 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Durability of the Adenosine Effect in Verification of Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT01590875
- Acronym / sponsor ID
- MCWPRO00016186
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation, pulmonary veins, adenosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Posted 3 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.
Detailed description
Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. Treatment group subjects will received 12 mg IV adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. If electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. Control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. If reconnection is observed, veins will be re-isolated per standard clinical practice. This procedure will be repeated for each of a patient's pulmonary veins. Patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenosine arm | Experimental | Drug: Adenosine arm25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. |
| Observation arm | No intervention | –25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter for standard clinical indications
Key exclusion criteria (5 listed)
- allergy or contraindication to adenosine,
- inability to give informed consent,
- currently taking dipyridamole,
- verapamil or theophylline and
- breast-feeding mothers.
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 |
|---|---|---|
| Adenosine armIn the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. | Drug | Adenosine arm |
Primary outcome
Pulmonary Vein Reconnection
Time frame: 5 minutes post infusion first dose adenosine
In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes after adenosine administration.
Pulmonary Vein Reconnection
Time frame: Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.
In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection. Criteria for pulmonary vein reconnection will be recurrence of local pulmonary vein electrical recordings noted on lasso catheter located within the vein. Pulmonary vein isolation is defined as disappearance of all local intracardiac electrograms within a pulmonary vein recorded on a 10 electrode circular catheter or lasso catheter positioned within the vein.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marcie G Berger, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine arm in people with Atrial Fibrillation, run by Medical College of Wisconsin 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 1 inclusion and 5 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 6 Nov 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 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?
Pulmonary Vein Reconnection (time frame: 5 minutes post infusion first dose adenosine). The study lists 2 primary outcomes in all. 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 6 Nov 2017.