Catheter Ablation Versus Antiarrhythmic Drugs for Outflow... | NCT01780311

Studies
Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

NCT01780311

Sponsor

Ospedale San Donato

Status

Unknown status

Last Update Posted

Jan 31, 2013Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Ventricular Tachycardia
Ventricular Premature Complexes

Interventions

antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
Catheter Ablation

Countries

Italy

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Not provided

First Submitted Date

Jan 25, 2013

First Submission Date that Met QC Criteria

Jan 30, 2013

First Posted Date

Jan 31, 2013Estimated

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

Jan 30, 2013

Last Update Posted Date

Jan 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias

Detailed Description

Not provided

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 4

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antiarrhythmic drugs	Active Comparator	Flecainide or Propafenone or Sotalol (oral, standard dosage)	Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
ABLATION	Experimental	Catheter Ablation	Procedure: Catheter Ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)	Drug		Antiarrhythmic drugs
Catheter Ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SF-36 score	Quality of life improvement according to SF-36 score variations	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. presence of ventricular ectopic beats (VEB) with left-bundle-branch block morphology or right-bundle-branch block morphology and positive concordance throughout the chest leads, inferior axis and at least one of the following:

>2000 isolated VEB/24h
symptomatic monomorphic ventricular tachycardia
left ventricular disfunction supposed to be due to tachycardia-induced cardiomyopathy

Exclusion Criteria:

known structural heart disease
pregnancy
life expectancy < 1 year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Department, Ospedale S.Donato	Recruiting	Arezzo	AR	52100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D017180	Tachycardia, Ventricular
D018879	Ventricular Premature Complexes

Ancestor Terms

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000889	Anti-Arrhythmia Agents
D005424	Flecainide
D011405	Propafenone
D013015	Sotalol
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D002317	Cardiovascular Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided