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The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.
Due to the lack of enrollments for the trial. The FDA and Medtronic discussed the inclusion of data found from from published literature (external studies) to corroborate study endpoint. The FDA allowed this data and the study was closed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freezor Catheter for AVNRT | Experimental | Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia. |
|
| External Data Supporting the Study | Other | This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freezor® Cardiac Cryoablation Catheter CryoConsole System | Device | cryoablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device or Procedure Related AV Block Persistent Through Discharge From Hospital. | After 250 subjects have been enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up. | After 250 subjects have been enrolled. |
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Inclusion Criteria:
Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria.
For inclusion in the study subjects must fulfill ALL of the following criteria:
Pre-EPS inclusion criteria:
Post-EPS inclusion criteria:
1. Patients with EPS-documented AVNRT
Exclusion Criteria:
ANY of the following is regarded as a criterion for excluding a subject from the study:
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| Name | Affiliation | Role |
|---|---|---|
| John Lehmann, MD, MPH | Lehmann Consulting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States | ||
| University of Nebraska Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15851143 | Background | Friedman PL, Dubuc M, Green MS, Jackman WM, Keane DT, Marinchak RA, Nazari J, Packer DL, Skanes A, Steinberg JS, Stevenson WG, Tchou PJ, Wilber DJ, Worley SJ. Catheter cryoablation of supraventricular tachycardia: results of the multicenter prospective "frosty" trial. Heart Rhythm. 2004 Jul;1(2):129-38. doi: 10.1016/j.hrthm.2004.02.022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Focal Cryoablation Group | Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia. Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation |
| FG001 | External Data Supporting the Study | Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 105 subjects gave actual consent in the study. Of the 105 consented 75 went on to have an ablation procedure performed. Data from 675 subjects were taken from published data that met inclusion criteria with publication search approved by the FDA.
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| ID | Title | Description |
|---|---|---|
| BG000 | Focal Cryoablation Group | Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia. Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation |
| BG001 | Subjects Consented in the Study Not Ablated |
| 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 | Device or Procedure Related AV Block Persistent Through Discharge From Hospital. | Posted | Number | 95% Confidence Interval | participants | After 250 subjects have been enrolled. |
|
|
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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 | Focal Cryoablation Group | Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia. Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation |
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Slow enrollment in the trial showed limited the amount of available data. Detailed subject data from the published literature was not available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Cline, MD, MSc.- Sr. Clinical Research Specialist | Medtronic- AF Solutions | 763-526-9601 | adam.cline@medtronic.com |
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| ID | Term |
|---|---|
| D013611 | Tachycardia, Atrioventricular Nodal Reentry |
| ID | Term |
|---|---|
| D054139 | Tachycardia, Reciprocating |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
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| Omaha |
| Nebraska |
| 63198-7835 |
| United States |
| Columbia University Medical Center and the New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
Actual Subjects that were consented in the study that did not meet inclusion criteria. |
| BG002 | Subjects Collected From Published Data | Published evidence about the safety and efficacy of using Medtronic's Freezor® 4 mm CryoCatheter has been reported since the initiation of the CryoFACTS-PAS. The results reported in the literature provide the supplemental data in the same study population as in the PAS and are included to meet the study objectives, as agreed upon with the FDA. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Baseline demographics were only collected for actual enrolled subjects (n=75) That were ablated. This data was not available for subjects enrolled from publicaton data (675). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up. | Posted | Number | 95% Confidence Interval | participants | After 250 subjects have been enrolled. |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | External Data Supporting the Study | Subjects from publication search with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia. Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation | 0 | 705 | 0 | 705 |
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| D002318 |
| Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |