Trial · NCT03032965
Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
NCT03032965, Phase 2, Completed, University of Michigan; results first posted 2017-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation. Trials, record NCT03032965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03032965
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
- NCT number
- NCT03032965
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Atrial Fibrillation
- Interventions
- Adenosine, Isoproterenol
- First posted
- 2017-01-26
- Last updated
- 2017-12-13
- Results first posted
- 2017-12-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Freedom From Any Atrial Arrhythmias | 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 |
| Secondary | Number of Subjects Who Need Repeat Ablations | date of ablation to 6 months after procedure | Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia. |
| Secondary | Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation | first three months post ablation | |
| Secondary | Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups | post-procedure (6 months) | 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. |
| Secondary | Incidence of Stroke | peri-procedural (0 to 30 days after procedure) | Number of subjects who develop stroke within 30 days after procedure. |
| Secondary | Incidence of Pulmonary Vein Stenosis | 6 months post-procedure | Number of subjects who develop Symptomatic pulmonary vein stenosis |
| Secondary | Incidence of Cardiac Perforation | within 24 hours | Number of subjects who develop perforation of heart during ablation |
| Secondary | Incidence of Atrio-esophageal Fistula | within 4 weeks | Number of subjects who develop connection between heart and the esophagus |
| Secondary | Incidence of Death | with 90 days of the procedure | Number of deaths within 90 days of the procedure. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Freedom From Any Atrial Arrhythmias | 2- 14 months after Ablation procedure | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Who Need Repeat Ablations | date of ablation to 6 months after procedure | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation | first three months post ablation | This data was not collected. | ||
| SECONDARY | Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups | post-procedure (6 months) | Only 21 participants had repeat ablations; each participant has four pulmonary veins therefore the number of connections measured is based 4 x the number of participants | pulmonary veins | COUNT_OF_UNITS |
| SECONDARY | Incidence of Stroke | peri-procedural (0 to 30 days after procedure) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Pulmonary Vein Stenosis | 6 months post-procedure | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Cardiac Perforation | within 24 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Atrio-esophageal Fistula | within 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Death | with 90 days of the procedure | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Freedom From Any Atrial Arrhythmias | Adenosine and Isoproterenol | 24 | Participants | ||
| Freedom From Any Atrial Arrhythmias | Isoproterenol | 23 | Participants | ||
| Number of Subjects Who Need Repeat Ablations | Adenosine and Isoproterenol | 12 | Participants | ||
| Number of Subjects Who Need Repeat Ablations | Isoproterenol | 9 | Participants | ||
| Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups | Adenosine and Isoproterenol | 29 | pulmonary veins | ||
| Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups | Isoproterenol | 28 | pulmonary veins | ||
| Incidence of Stroke | Adenosine and Isoproterenol | 0 | Participants | ||
| Incidence of Stroke | Isoproterenol | 0 | Participants | ||
| Incidence of Pulmonary Vein Stenosis | Adenosine and Isoproterenol | 0 | Participants | ||
| Incidence of Pulmonary Vein Stenosis | Isoproterenol | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adenosine and Isoproterenol | 61 | |
| Overall Study | STARTED | Isoproterenol | 68 | |
| Overall Study | COMPLETED | Adenosine and Isoproterenol | 61 | |
| Overall Study | COMPLETED | Isoproterenol | 68 | |
| Overall Study | NOT COMPLETED | Adenosine and Isoproterenol | 0 | |
| Overall Study | NOT COMPLETED | Isoproterenol | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Site hematoma | Vascular disorders | Adenosine and Isoproterenol | 2 | 61 | |
| serious | Site hematoma | Vascular disorders | Isoproterenol | 2 | 68 | |
| serious | Pericardial Effusion | Vascular disorders | Adenosine and Isoproterenol | 1 | 61 | |
| serious | Pericardial Effusion | Vascular disorders | Isoproterenol | 0 | 68 | |
| serious | A V Fistula | Vascular disorders | Adenosine and Isoproterenol | 1 | 61 | |
| serious | A V Fistula | Vascular disorders | Isoproterenol | 0 | 68 | |
| serious | Transient phrenic nerve paralysis | Respiratory, thoracic and mediastinal disorders | Adenosine and Isoproterenol | 0 | 61 | |
| serious | Transient phrenic nerve paralysis | Respiratory, thoracic and mediastinal disorders | Isoproterenol | 1 | 68 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adenosine and Isoproterenol | 0 | 61 |
| Total, all-cause mortality | Isoproterenol | 0 | 68 |
| Total, other adverse events | Adenosine and Isoproterenol | 0 | 61 |
| Total, other adverse events | Isoproterenol | 0 | 68 |
| Total, serious adverse events | Adenosine and Isoproterenol | 4 | 61 |
| Total, serious adverse events | Isoproterenol | 3 | 68 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adenosine and Isoproterenol vs Isoproterenol: Incidence of Cardiac Perforation | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: Incidence of Pulmonary Vein Stenosis | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: Number of Subjects Who Need Repeat Ablations | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: Incidence of Death | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: Incidence of Stroke | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: deaths from any cause | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: Incidence of Atrio-esophageal Fistula | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: Freedom From Any Atrial Arrhythmias | Trial comparisons |
| Adenosine and Isoproterenol vs Isoproterenol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03032965
GET https://conductscience.org/api/trials/v1/NCT03032965/registered