Trial Outcomes & Findings for CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) (NCT NCT00621621)
NCT ID: NCT00621621
Last Updated: 2018-10-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
After 250 subjects have been enrolled.
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
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
|
External Data Supporting the Study
Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
705
|
|
Overall Study
COMPLETED
|
75
|
705
|
|
Overall Study
NOT COMPLETED
|
30
|
0
|
Reasons for withdrawal
| Measure |
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
|
External Data Supporting the Study
Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
|
|---|---|---|
|
Overall Study
Subjects were exited at EP study
|
30
|
0
|
Baseline Characteristics
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
Baseline characteristics by cohort
| Measure |
Focal Cryoablation Group
n=75 Participants
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
|
Subjects Consented in the Study Not Ablated
n=30 Participants
Actual Subjects that were consented in the study that did not meet inclusion criteria.
|
Subjects Collected From Published Data
n=675 Participants
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.
|
Total
n=780 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 17.8 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
30 participants
n=7 Participants
|
NA participants
n=5 Participants
|
NA participants
n=4 Participants
|
PRIMARY outcome
Timeframe: After 250 subjects have been enrolled.Outcome measures
| Measure |
Focal Cryoablation Group
n=75 Participants
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
|
External Data Supporting the Study
n=705 Participants
|
|---|---|---|
|
Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
|
0 participants
Interval 0.0 to 0.5
|
0 participants
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: After 250 subjects have been enrolled.Outcome measures
| Measure |
Focal Cryoablation Group
n=75 Participants
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
|
External Data Supporting the Study
n=705 Participants
|
|---|---|---|
|
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
Interval 0.0 to 0.5
|
0 participants
Interval 0.0 to 0.5
|
Adverse Events
Focal Cryoablation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
External Data Supporting the Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Adam Cline, MD, MSc.- Sr. Clinical Research Specialist
Medtronic- AF Solutions
Phone: 763-526-9601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60