Tachycardia, Atrioventricular Nodal Reentry
Conditions
Keywords
atrioventricular nodal reentrant tachycardia, AVNRT
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFreezor® Cardiac Cryoablation Catheter CryoConsole System
cryoablation
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Patients with a clinical history of AVNRT who are referred for ablation. 2. Patients willing to provide written informed consent. 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: 1. Patients with any pre-existing AV block. 2. Patients with known cryoglobulinemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device or Procedure Related AV Block Persistent Through Discharge From Hospital. | After 250 subjects have been enrolled. |
Secondary
| Measure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 75 |
| Subjects Consented in the Study Not Ablated Actual Subjects that were consented in the study that did not meet inclusion criteria. | 30 |
| 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. | 675 |
| Total | 780 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subjects were exited at EP study | 30 | 0 |
Baseline characteristics
| Characteristic | Focal Cryoablation Group | Subjects Consented in the Study Not Ablated | Subjects Collected From Published Data | Total |
|---|---|---|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 17.8 | NA years | NA years | NA years |
| Region of Enrollment United States | 75 participants | 30 participants | NA participants | NA participants |
| Sex: Female, Male Female | 55 Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | 20 Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 705 |
| serious Total, serious adverse events | 0 / 75 | 0 / 705 |
Outcome results
Primary
Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
Time frame: After 250 subjects have been enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Focal Cryoablation Group | Device or Procedure Related AV Block Persistent Through Discharge From Hospital. | 0 participants |
| External Data Supporting the Study | Device or Procedure Related AV Block Persistent Through Discharge From Hospital. | 0 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.
Time frame: After 250 subjects have been enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Focal Cryoablation Group | 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. | 0 participants |
| External Data Supporting the Study | 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. | 0 participants |