NCT00606463

Brief Summary

Irrigated catheter for ablation of isthmus-dependent atrial flutter

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

3 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

January 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

January 21, 2008

Last Update Submit

July 13, 2023

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraprocedural, serious cardiac adverse event

    Defined as the Incidence of intraprocedural, serious cardiac adverse event

    7 days post-procedure

Other Outcomes (1)

  • Bi-direction block and non-inducibility of atrial flutter

    Procedural

Study Arms (1)

(Gen2 Cardiac Ablation System)

EXPERIMENTAL

Ablation of isthmus-dependent atrial flutter

Device: Cardiac Ablation (Gen2 Cardiac Ablation System)

Interventions

Cardiac Ablation (Gen2 Cardiac Ablation System)DEVICE

Ablation of isthmus-dependent atrial flutter

(Gen2 Cardiac Ablation System)

Eligibility Criteria

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

You may qualify if:

  • Scheduled for ablation of isthmus-dependent atrial flutter

You may not qualify if:

  • Prior ablation of isthmus-dependent atrial flutter
  • Atypical or scar flutter
  • Significant heart disease
  • Intracardiac thrombus
  • Prior cardiac surgery (within 1 month)
  • Contraindication to heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama Birmingham

Birmingham, Alabama, United States

Location

St. Barnabus Medical Center

West Orange, New Jersey, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, United States

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Vance Plumb, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 4, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2008

Study Completion

January 1, 2009

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)