KONVERT-AF - Relevance of Point in Time for Conversion of... | NCT00369330

Studies
KONVERT-AF - Relevance of Point in Time for Conversion of Acute Atrial Fibrillation

NCT00369330

Sponsor

Atrial Fibrillation Network

Status

Withdrawn

Last Update Posted

Sep 3, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

external electrical cardioversion

Countries

Germany

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

Aug 2006

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

withdrawn because of insufficient financial capacities

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 28, 2006

First Submission Date that Met QC Criteria

Aug 28, 2006

First Posted Date

Aug 29, 2006Estimated

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

Aug 31, 2012

Last Update Posted Date

Sep 3, 2012Estimated

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV

Description Module

Brief Summary

To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion.

Detailed Description

So far it is unknown if early or delayed cardioversion is most beneficial for patient outcome and which strategy is best to prevent recurrence of AF. The KONVERT-AF trial investigates if in acute symptomatic AF the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion. Primary endpoint is the time to the first recurrence of AF. The KONVERT-AF trial will be conducted as prospective, randomized, non-blinded multicentre study. It is planned to include 380 patients in 10-20 recruitment centres.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
external electrical cardioversion	Device

Outcomes Module

Primary Outcomes

Not provided

Secondary Outcomes

Measure	Description	Time Frame
Number of electrical cardioversion because of AF
Need to initiate or change medical antiarrhythmic treatment because of recurrence of AF
Number and length of stay of hospitalization because of cardiovascular reasons
Number of thromboembolic events
Number of therapy non-responder and early recurrence of AF
AF burden

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

documented AF that began between 2 and 8 hrs before randomization
indication for electrical cardioversion.
age above 18 yrs
written informed consent

Exclusion Criteria:

AF caused by not adequately treated reversible conditions(e.g. myocardial infarction, thyrotoxicosis, ethanol intoxication, infection, pericarditis, surgery)
newly initiated (i.e. within 7 days before randomization) antiarrhythmic agents of class I, II and/or III
catheter ablation of AF within 3 months before randomization
pacemaker or icd
myocardial infarction within 3 months before randomization
urgent need to cardioversion of AF because of associated potentially dangerous symptoms such as chest pain, syncope, dyspnea
contraindications for therapy with vitamin k-antagonists
intracardial thrombus
primary indication for pharmacological cardioversion
in females: pregnancy, lactation period or no sufficient contraception within last 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thorsten Lewalter, MD	Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Klinik und Poliklinik II, University Hospital of Bonn		Bonn		53105	Germany

Label	URL
Homepage of german atrial fibrillation network	View source

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