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Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.
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To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency Ablation | Active Comparator | PVI using RF ablation |
|
| Visually Guided Ablation | Experimental | PVI using visually guided ablation with an endoscopic ablation system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopically guided PVI Ablation | Device | Endoscopically Guided Ablation using the EAS-AC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation | Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs). | 3 Months |
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | The Mount Sinai Hospital, New York City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine (IKEM) | Prague | 140 21 | Czechia | |||
| Catholic University of the Sacred Heart |
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| Label | URL |
|---|---|
| Related Info | View source |
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The Sponsor stopped the study for business reasons before any participants were enrolled in the RF arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Ablation | Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation |
| FG001 | Visually Guided Ablation | Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visually Guided Ablation | Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation |
| 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 | Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation | Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs). | Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation. | Posted | Number | isolated pulmonary veins | 3 Months |
|
|
Up to 3 months after treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visually Guided Ablation | Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Burke Barrett, VP, Regulatory & Clinical Affairs | CardioFocus, Inc. | 508 658-7200 | bbarrett@cardiofocus.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| RF PVI Ablation | Device | Radiofrequency ablation |
|
| Rome |
| 00168 |
| Italy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 2 |
| 19 |
| 0 |
| 19 |
| Groin bleed | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |