Safety and Efficacy of the CryoCor™ Cardiac Cryoablation... | NCT00113178

Studies
Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter

NCT00113178

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Feb 24, 2011Estimated

Enrollment

160

Phase

Phase 3

Conditions

Atrial Flutter

Interventions

Catheter-based cardiac cryoablation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Jun 2005Actual

First Submitted Date

Jun 6, 2005

First Submission Date that Met QC Criteria

Jun 6, 2005

First Posted Date

Jun 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2011

Last Update Posted Date

Feb 24, 2011Estimated

Description Module

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.

Detailed Description

Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy. Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients with atrial flutter.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
Catheter-based cardiac cryoablation	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic atrial flutter

Exclusion Criteria:

Prior ablation
Contraindication to intervention
Poor general health

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D001282	Atrial Flutter

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Acute efficacy
Acute safety

Measure	Description	Time Frame
Long-term efficacy
Long-term safety