Catheter Ablation for Recently Diagnosed Paroxysmal Atria... | NCT01505296

Studies
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

NCT01505296

Sponsor

Valley Health System

Status

Withdrawn

Last Update Posted

Dec 16, 2014Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

Antiarrhythmic drug
Catheter ablation

Countries

United States
Russia

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

Dec 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never initiated

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Dec 28, 2011

First Submission Date that Met QC Criteria

Jan 3, 2012

First Posted Date

Jan 6, 2012Estimated

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

Dec 13, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Name	Class
Biosense Webster, Inc.	INDUSTRY

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

The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.

Detailed Description

Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.

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

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antiarrhythmic drug	Active Comparator	Class I or III antiarrhythmic drug	Drug: Antiarrhythmic drug
Catheter ablation	Experimental	Pulmonary vein isolation	Procedure: Catheter ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antiarrhythmic drug	Drug	propafenone, flecainide, sotalol, dofetilide	Antiarrhythmic drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of AF burden	The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)	4 months

Secondary Outcomes

Measure	Description	Time Frame
All-death death	All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy

Exclusion Criteria:

Previous treatment with Class IC or class III AAD
Previous AF ablation procedure
Congestive heart failure (NYHA III-IV functional class)
Left Ventricle ejection fraction less than 35%
Left atrial diameter > 55mm
Unwillingness to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan Steinberg, MD	Valley Health System	Principal Investigator
Evegny Pokushalou, MD	State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Valley Health System		Ridgewood	New Jersey	07450	United States
State Research Institute of Circulation Pathology

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000889	Anti-Arrhythmia Agents
D005424	Flecainide
D013015	Sotalol
C063533	dofetilide
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