Condition category
Circulatory System
Date applied
27/11/2007
Date assigned
11/12/2007
Last edited
11/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bernhard Richter

ORCID ID

Contact details

Waehringer Guertel 18-20
Vienna
1090
Austria
+43 (0)1 40400 4614
bernhard.richter@meduniwien.ac.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07098 (ref. no. of The Medical-Scientific Fund of the Mayor of Vienna)

Study information

Scientific title

Time course of biochemical markers of inflammation, oxidative stress and wound healing after ablation of atrial fibrillation

Acronym

Study hypothesis

1. Radiofrequency ablation of Atrial Fibrillation (AF) affects biochemical markers of inflammation, oxidative stress and wound healing
2. The ablation-induced changes of the assessed biochemical markers correlate with the ablation-induced structural changes, with the amount of energy applied during ablation and with the AF recurrence rate after ablation

Ethics approval

Ethics approval received from the Ethics Committee of the Medical University of Vienna on the 13th February 2007 (ref: 028/2007) - www.meduniwien.ac.at/ethik.

Study design

Observational, prospective, single centre, longitudinal study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Atrial fibrillation

Intervention

Observational trial:
The included patients will undergo a radiofrequency ablation procedure comprising:
1. A CARTO-guided left atrial circumferential ablation
2. A Lasso-guided segmental pulmonary vein isolation, and
3. Ablation of complex fractionated potentials

Venous blood sampling will be performed before and 6 hours, 24 hours, 48 hours, 7, 28, 90 and 180 days after ablation in order to determine biochemical markers of inflammation, wound healing and oxidative stress. Transthoracal echocardiography and cardiac MRI will be conducted before and 6 months after ablation in order to assess ablation-induced structural changes. Successful ablation will be defined as no recurrence of atrial fibrillation persisting or developing beyond a period of 3 months after ablation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Biochemical markers of inflammation, oxidative stress and wound healing at the above specified timepoints
2. Ablation-induced structural atrial changes evaluated by MRI and echocardiography at the above specified timepoints

Secondary outcome measures

1. Correlation of the assessed biochemical markers with ablation-induced structural changes, energy application data and AF recurrence rate after ablation
2. Complications

Overall trial start date

30/11/2007

Overall trial end date

01/08/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Genders eligible for study: both
2. Age older than 18 years
3. Symptomatic, drug-resistant paroxysmal atrial fibrillation (self-terminating episodes lasting less than 7 days)
4. Patients referred to our department for catheter ablation of atrial fibrillation
5. Adequate anticoagulation for at least 1 month prior to admission (oral anticoagulation (target International Normalised Ratio [INR] 2 to 3) or treatment with weight-adjusted low-molecular-weight heparin

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Pregnancy
2. Ongoing infections
3. Intracardiac thrombosis detected by trans-oesophageal echocardiography
4. Contraindications to anticoagulation
5. History of myocardial infarction or cardiac surgery within the last 3 months prior to admission
6. Pacemaker or other contraindications to Magnetic Resonance Imaging (MRI)
7. Denial or withdrawal of informed consent
8. Life expectancy less than 1 year

Recruitment start date

30/11/2007

Recruitment end date

01/08/2008

Locations

Countries of recruitment

Austria

Trial participating centre

Waehringer Guertel 18-20
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna (Austria)

Sponsor details

Department of Internal Medicine II
Division of Cardiology
Währinger Gürtel 18-20
Vienna
1090
Austria

Sponsor type

University/education

Website

http://www.meduniwien.ac.at/

Funders

Funder type

Government

Funder name

The Medical-Scientific Fund of the Mayor of Vienna (Medizinisch-Wissenschaftlicher Fonds des Burgermeisters der Bundeshauptstadt Wien) (Austria) (ref: 07098) - http://www.wien.gv.at/fonds/gesundheit/index.htm

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes