Inflammation, oxidative stress and wound healing after ablation of atrial fibrillation
| ISRCTN | ISRCTN89619994 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89619994 |
| Secondary identifying numbers | 07098 (ref. no. of The Medical-Scientific Fund of the Mayor of Vienna) |
- Submission date
- 27/11/2007
- Registration date
- 11/12/2007
- Last edited
- 31/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bernhard Richter
Scientific
Scientific
Waehringer Guertel 18-20
Vienna
1090
Austria
| Phone | +43 (0)1 40400 4614 |
|---|---|
| bernhard.richter@meduniwien.ac.at |
Study information
| Study design | Observational, prospective, single centre, longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Time course of biochemical markers of inflammation, oxidative stress and wound healing after ablation of atrial fibrillation |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/11/2007 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/11/2007 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Austria
Study participating centre
Waehringer Guertel 18-20
Vienna
1090
Austria
1090
Austria
Sponsor information
Medical University of Vienna (Austria)
University/education
University/education
Department of Internal Medicine II
Division of Cardiology
Währinger Gürtel 18-20
Vienna
1090
Austria
| Website | http://www.meduniwien.ac.at/ |
|---|---|
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
Government
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
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/10/2011 | 31/05/2019 | Yes | No |
| Results article | results | 01/03/2012 | 31/05/2019 | Yes | No |
Editorial Notes
31/05/2019: Publication reference and total final enrolment added.
