NCT00113178

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2005

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

First QC Date

June 6, 2005

Last Update Submit

February 23, 2011

Conditions

Atrial Flutter

Keywords

atrial fluttercryoablation

Outcome Measures

Primary Outcomes (2)

  • Acute efficacy

  • Acute safety

Secondary Outcomes (2)

  • Long-term efficacy

  • Long-term safety

Interventions

Catheter-based cardiac cryoablationDEVICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic atrial flutter

You may not qualify if:

  • Prior ablation
  • Contraindication to intervention
  • Poor general health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2005

First Posted

June 7, 2005

Study Start

January 1, 2004

Study Completion

June 1, 2005

Last Updated

February 24, 2011

Record last verified: 2011-02