Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Hypothesis:
Objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adenosine and Isoproterenol | Experimental | Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction. |
|
| Isoproterenol | Other | This group will not receive adenosine during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hamid Ghanbari, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Two subjects were not randomized.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adenosine and Isoproterenol | Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction. Adenosine: 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. Isoproterenol: 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. |
| FG001 | Isoproterenol | This group will not receive adenosine during the procedure. Isoproterenol: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adenosine and Isoproterenol | Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction. Adenosine: 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. Isoproterenol: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 2- 14 months after Ablation procedure |
|
within 24 hours of procedure
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adenosine and Isoproterenol | Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction. Adenosine: 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. Isoproterenol: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Site hematoma | Vascular disorders | Non-systematic Assessment | Femoral vein/groin hematoma. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hamid Ghanbari | University of Michigan | 734-963-7141 | ghhamid@med.umich.edu |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D007545 | Isoproterenol |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| 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. | post-procedure (6 months) |
| Incidence of Stroke | Number of subjects who develop stroke within 30 days after procedure. | peri-procedural (0 to 30 days after procedure) |
| Incidence of Pulmonary Vein Stenosis | Number of subjects who develop Symptomatic pulmonary vein stenosis | 6 months post-procedure |
| Incidence of Cardiac Perforation | Number of subjects who develop perforation of heart during ablation | within 24 hours |
| Incidence of Atrio-esophageal Fistula | Number of subjects who develop connection between heart and the esophagus | within 4 weeks |
| Incidence of Death | Number of deaths within 90 days of the procedure. | with 90 days of the procedure |
| BG001 | Isoproterenol | This group will not receive adenosine during the procedure. Isoproterenol: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Left ventricular ejection fraction | Mean | Standard Deviation | Percentage |
|
| left atrial diameter | Mean | Standard Deviation | milli meters |
|
| Hypertension | Participants with a documented history of hypertension or being treated for hypertension with medications | Count of Participants | Participants |
|
| Diabetes Mellitus | participants with a history of diabetes mellitus or current treatment for diabetes | Count of Participants | Participants |
|
| Obstructive sleep apnea | participants with a history of obstructive sleep apnea | Count of Participants | Participants |
|
| Cerebrovascular accident | participants with a history of cerebrovascular accident | Count of Participants | Participants |
|
| Repeat procedure | These are patients who had a previous ablation prior to entering the study | Count of Participants | Participants |
|
| CHADS2 Score ( Congestive heart failure, Hypertension, Age > 75 years, Diabetes Mellitus, Stroke | Each of these five variables is given 1 point for its presence, except stroke is given 2 points. Each individual point is added, so the score ranges possible are 0 to 6 where 0 represents no risk factors and 6 represents highest number of risk factors. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Isoproterenol | This group will not receive adenosine during the procedure. Isoproterenol: 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. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | date of ablation to 6 months after procedure |
|
|
|
|
| Secondary | Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation | This data was not collected. | Posted | first three months post ablation |
|
|
| Secondary | 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. | 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 | Posted | Count of Units | pulmonary veins | post-procedure (6 months) | pulmonary veins | pulmonary veins |
|
|
|
|
| Secondary | Incidence of Stroke | Number of subjects who develop stroke within 30 days after procedure. | Posted | Count of Participants | Participants | peri-procedural (0 to 30 days after procedure) |
|
|
|
| Secondary | Incidence of Pulmonary Vein Stenosis | Number of subjects who develop Symptomatic pulmonary vein stenosis | Posted | Count of Participants | Participants | 6 months post-procedure |
|
|
|
| Secondary | Incidence of Cardiac Perforation | Number of subjects who develop perforation of heart during ablation | Posted | Count of Participants | Participants | within 24 hours |
|
|
|
| Secondary | Incidence of Atrio-esophageal Fistula | Number of subjects who develop connection between heart and the esophagus | Posted | Count of Participants | Participants | within 4 weeks |
|
|
|
| Secondary | Incidence of Death | Number of deaths within 90 days of the procedure. | Posted | Count of Participants | Participants | with 90 days of the procedure |
|
|
|
| 0 |
| 61 |
| 4 |
| 61 |
| 0 |
| 61 |
| EG001 | Isoproterenol | This group will not receive adenosine during the procedure. Isoproterenol: 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. | 0 | 68 | 3 | 68 | 0 | 68 |
|
| Pericardial Effusion | Vascular disorders | Systematic Assessment | Pericardial effusion with hemodynamic compromise. |
|
| A V Fistula | Vascular disorders | Systematic Assessment | Arterio venous fistula between femoral artery and vein. |
|
| Transient phrenic nerve paralysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Phrenic nerve paralysis. |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |