PS-010: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00621621
• Collaborator: (none)
• Enrollment: 105
• Locations: 4
• Arms: 2
• Duration (Months): 84
• Patients Per Site: 26.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tachycardia, Atrioventricular Nodal Reentry	Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Freezor Catheter for AVNRT Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.	Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System; cryoablation; Other Names: 7F Freezor Cardiac CryoAblation Catheter
Other: External Data Supporting the Study This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.	Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System; cryoablation; Other Names: 7F Freezor Cardiac CryoAblation Catheter

Outcome Measures

Primary Outcome Measures

1. Device or Procedure Related AV Block Persistent Through Discharge From Hospital. [After 250 subjects have been enrolled.]

Secondary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
2	University of Nebraska Medical Center	Omaha	Nebraska	United States	63198-7835
3	Columbia University Medical Center and the New York Presbyterian Hospital	New York	New York	United States	10032
4	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: John Lehmann, MD, MPH, Lehmann Consulting

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00621621
• Other Study ID Numbers: PS-010
• First Posted: Feb 22, 2008
• Last Update Posted: Oct 16, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: atrioventricular nodal reentrant tachycardia; AVNRT
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Atrioventricular Nodal Reentry

Study Results

Participant Flow

Arm/Group Title	Focal Cryoablation Group	External Data Supporting the Study
Arm/Group Description	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	Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
Period Title: Overall Study
STARTED	105	705
COMPLETED	75	705
NOT COMPLETED	30	0

Baseline Characteristics

Arm/Group Title	Focal Cryoablation Group	Subjects Consented in the Study Not Ablated	Subjects Collected From Published Data	Total
Arm/Group Description	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	Actual Subjects that were consented in the study that did not meet inclusion criteria.	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 of all reporting groups
Overall Participants	75	30	675	780
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.5 (17.8)	NA (NA)	NA (NA)	NA (NA)
Sex: Female, Male (Count of Participants)
Female	55 73.3%	NA NaN	NA NaN	NA NaN
Male	20 26.7%	NA NaN	NA NaN	NA NaN
Region of Enrollment (participants) [Number]
United States	75 100%	30 100%	NA NaN	NA NaN

Outcome Measures

1. Primary Outcome

Title	Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
Time Frame	After 250 subjects have been enrolled.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Focal Cryoablation Group	External Data Supporting the Study
Arm/Group Description	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
Measure Participants	75	705
Number (95% Confidence Interval) [participants]	0 0%	0 0%

2. Secondary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Freezor Catheter for AVNRT	External Data Supporting the Study
Arm/Group Description	Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmiacryoablation	This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
Measure Participants	75	705
Number (95% Confidence Interval) [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Focal Cryoablation Group		External Data Supporting the Study
Arm/Group Description	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 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
All Cause Mortality
	Focal Cryoablation Group		External Data Supporting the Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Focal Cryoablation Group		External Data Supporting the Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/705 (0%)
Other (Not Including Serious) Adverse Events
	Focal Cryoablation Group		External Data Supporting the Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/705 (0%)

Limitations/Caveats

Slow enrollment in the trial showed limited the amount of available data. Detailed subject data from the published literature was not available.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.