Tachycardia, Atrioventricular Nodal ReentryPhase 4PS-010NCT00621621

CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

A Phase 4 study testing Freezor® Cardiac Cryoablation Catheter CryoConsole System in people with Tachycardia, Atrioventricular Nodal Reentry, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tachycardia, Atrioventricular Nodal Reentry
What is being tested?: Freezor® Cardiac Cryoablation Catheter CryoConsole System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 4 sitesUnited States
Study dates: Dec 2006to Dec 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
Patients with a clinical history of AVNRT who are referred for ablation.
Patients willing to provide written informed consent.
Post-EPS inclusion criteria:
1. Patients with EPS-documented AVNRT

Who cannot join

ANY of the following is regarded as a criterion for excluding a subject from the study:
Patients with any pre-existing AV block.
Patients with known cryoglobulinemia

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Columbia University Medical Center and the New York Presbyterian Hospital
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 63198-7835

Other trials in United States

About this study

Read the 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.

Conditions: Tachycardia, Atrioventricular Nodal Reentry
Being tested: Freezor® Cardiac Cryoablation Catheter CryoConsole System
Keywords: atrioventricular nodal reentrant tachycardia, AVNRT
Medical subject headings: Tachycardia, Atrioventricular Nodal Reentry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Freezor® Cardiac Cryoablation Catheter CryoConsole SystemDevice
Also called 7F Freezor Cardiac CryoAblation Catheter
cryoablation

Study groups in NCT00621621
Study group	Role	What they receive
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. Receives: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
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. Receives: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System

What is being measured

The primary outcome is the main question the study is designed to answer.

Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
Measured: After 250 subjects have been enrolled.

Secondary outcomes (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.
Measured: After 250 subjects have been enrolled.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Dec 2013

First posted22 Feb 2008 (estimated)
Study startDec 2006
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tachycardia, Atrioventricular Nodal ReentryStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621621
Sponsor's protocol ID: PS-010
Acronym: PS-010
Status last verified: Sep 2018
First submitted: 13 Feb 2008
Last updated: 16 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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. doi: 10.1016/j.hrthm.2004.02.022.
PubMed 15851143

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia
Supraventricular Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.
Atrioventricular Nodal Reentry Tachycardia, Supraventricular Tachycardia
Not yet recruitingObservational study
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome
Not yet recruiting
Differentiate AVNRT from Orthodromic AVRT
SVT
Enrolling by invitationObservational study
Intracardiac Echocardiography Guided Slow Pathway Cryoablation
Atrioventricular Nodal Reentry Tachycardia

All Tachycardia, Atrioventricular Nodal Reentry trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
ClinicalTrials.gov ID: NCT00621621
Acronym / sponsor ID: PS-010 / PS-010
Conditions: Tachycardia, Atrioventricular Nodal Reentry
Keywords: atrioventricular nodal reentrant tachycardia, AVNRT
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 23 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Freezor Catheter for AVNRT	Experimental	Device: Freezor® Cardiac Cryoablation Catheter CryoConsole SystemSubjects 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	Device: Freezor® Cardiac Cryoablation Catheter CryoConsole SystemThis arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria.
Patients with a clinical history of AVNRT who are referred for ablation.
Patients willing to provide written informed consent.
1. Patients with EPS-documented AVNRT

Key exclusion criteria (3 listed)

Patients with any pre-existing AV block.
Patients with known cryoglobulinemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Freezor® Cardiac Cryoablation Catheter CryoConsole SystemAlso: 7F Freezor Cardiac CryoAblation Cathetercryoablation	Device	External Data Supporting the Study, Freezor Catheter for AVNRT

Primary outcome

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

1 secondary outcome

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.

Results and safety

Results posted to the registry on 23 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Focal Cryoablation Group	105	75
External Data Supporting the Study	705	705

Primary outcome: Device or Procedure Related AV Block Persistent Through Discharge From Hospital.

Time frame: After 250 subjects have been enrolled.. Number (95% Confidence Interval). Unit: participants

Measure	Focal Cryoablation Group n = 75	External Data Supporting the Study n = 705
Value	0 (0.0 to 0.5)	0 (0.0 to 0.5)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Focal Cryoablation Group	0 of 75 (0%)	0 of 75 (0%)	Not reported
External Data Supporting the Study	0 of 705 (0%)	0 of 705 (0%)	Not reported

Limitations and caveats (from the sponsor): Slow enrollment in the trial showed limited the amount of available data. Detailed subject data from the published literature was not available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15851143Friedman 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.

Related trials for Tachycardia, Atrioventricular Nodal Reentry

Recruiting
NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia
Supraventricular Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.
Atrioventricular Nodal Reentry Tachycardia, Supraventricular Tachycardia
Not yet recruitingObservational study
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome
Not yet recruiting
Differentiate AVNRT from Orthodromic AVRT
SVT
Enrolling by invitationObservational study
Intracardiac Echocardiography Guided Slow Pathway Cryoablation
Atrioventricular Nodal Reentry Tachycardia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Lehmann, MD, MPH principal investigator

Lehmann Consulting

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device or Procedure Related AV Block Persistent Through Discharge From Hospital. (time frame: After 250 subjects have been enrolled.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00621621, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.