NCT00621621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 23, 2015

Completed
Last Updated

October 16, 2018

Status Verified

September 1, 2018

Enrollment Period

7 years

First QC Date

February 13, 2008

Results QC Date

July 22, 2014

Last Update Submit

September 17, 2018

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Keywords

atrioventricular nodal reentrant tachycardiaAVNRT

Outcome Measures

Primary Outcomes (1)

  • Device or Procedure Related AV Block Persistent Through Discharge From Hospital.

    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.

    After 250 subjects have been enrolled.

Study Arms (2)

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.

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.

Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System

Interventions

Freezor® Cardiac Cryoablation Catheter CryoConsole SystemDEVICE

cryoablation

Also known as: 7F Freezor Cardiac CryoAblation Catheter
External Data Supporting the StudyFreezor Catheter for AVNRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a clinical history of AVNRT who are referred for ablation.
  • Patients willing to provide written informed consent.
  • \. Patients with EPS-documented AVNRT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 63198-7835, United States

Location

Columbia University Medical Center and the New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

    PMID: 15851143BACKGROUND

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia, ReciprocatingTachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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

Results Point of Contact

Title
Adam Cline, MD, MSc.- Sr. Clinical Research Specialist
Organization
Medtronic- AF Solutions
adam.cline@medtronic.com
763-526-9601

Study Officials

  • John Lehmann, MD, MPH

    Lehmann Consulting

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 22, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 16, 2018

Results First Posted

April 23, 2015

Record last verified: 2018-09

Locations

US(4)