NCT01032317

Brief Summary

The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 atrial-fibrillation

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 11, 2009

Last Update Submit

December 2, 2014

Conditions

Atrial FibrillationIschemic Ventricular Tachycardia

Keywords

ArrhythmiaElectrophysiologyFibrillationTachycardiaAblationAtrial Fibrillation (AF)Ischemic Ventricular Tachycardia (VT)

Outcome Measures

Primary Outcomes (1)

  • The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.

    The primary safety endpoint is the incidence of early onset primary adverse events.

    7 days

Study Arms (1)

Single-arm Study

OTHER

This study was completed prior to the implementation of the requirement for specific identification of study arms. As the requirement was not made retroactive to completed studies, we believe this study to be exempt from the stipulation. Also, per PRS definition, since this is for a single-arm/feasibility study, the data elements are optional.

Device: Radiofrequency Catheter Ablation

Interventions

Radiofrequency Catheter AblationDEVICE

The Biosense Webster EZ Steer ThermoCool NAV Diagnostic / Ablation Deflectable Tip Catheter with Contact Force Sensing Capability is designed to facilitate electrophysiological mapping and transmit radiofrequency current as well as provide a real-time measurement of contact force.

Single-arm Study

Eligibility Criteria

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

You may qualify if:

  • Symptomatic atrial fibrillation or ischemic ventricular tachycardia

You may not qualify if:

  • Longstanding persistent AF
  • Idiopathic VT
  • Congestive Heart Failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IKEM

Prague, Czechia

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacTachycardia

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2009

First Posted

December 15, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

CZ(1)