Comparison of COOL-Tip catheters vs Usual 4 mm catheters for radiofrequency ablation of accessory pathways and idiopathic ventricular arrhythmias
| ISRCTN | ISRCTN06594397 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06594397 |
| Protocol serial number | ELM-1 |
| Sponsor | ElMedica (Poland) |
| Funder | Investigator initiated and funded (Poland) |
- Submission date
- 23/01/2013
- Registration date
- 16/05/2013
- Last edited
- 01/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This study aims to compare the efficiency between catheters used for radiofrequency ablation (RFCA), a procedure to correct irregularity in the heart rhythm, of accessory pathways in the heart and irregular heartbeat (arrhythmia). Our goal is to find the best catheter and energy settings for different locations of irregularity (arrhythmic focus). For many years, non-irrigated tip catheters have been used for this procedure. Irrigated-tip catheters work better and have fewer risks of blood clot. We want to look at whether COOL-Tip catheters can be used as a universal catheter for all locations and whether they work faster.
Who can participate?
The study aims to recruit about 200 patients, both male and female of age > 18 years from 4 Polish hospitals: Warsaw, Wroclaw, Radom and Ostrowiec Swietokrzyski.
What does the study involve?
Patients will be randomly allocated to two groups: one receiving treatment with COOL-Tip catheters and the other with the usual 4mm catheters. Patients will be followed for 12 months after the procedure. Arrhythmia or ACP recurrence data, information about the course of the procedure and information regarding early and late complications will be collected. Observation will include follow-up visits 1, 6 and 12 months after the RFCA procedure. A standard internet-based database will be provided to all participating sites. It will include standard electronic study forms and documentation of the clinical status of the patient. Follow-up visits will be conducted by an electrophysiology specialist in an outpatient setting. Before each follow-up visit, a 24-hour Holter test (to continuously record the heart's rhythms) will be scheduled. In case of undocumented pounding or racing of heart, typical of the ablated arrhythmia, the patient shall receive an arrhythmia recorder to confirm the recurrence of the ablated arrhythmia. If information could not be collected during follow-up visits, it will be recorded by a qualified nurse during analysis of the patient files, the patients family files, medical data and medical files kept by the general practitioner/treating physician.
What are the possible benefits and risks of participating?
Performance of the procedure by an experienced specialist will be the benefit for the patient, regardless of the random group assignment. Upon inclusion in the study, the patient benefits from contact and follow-up visits within 12 months of the procedure, conducted directly by the specialist performing the ablation procedure. Approved catheters bearing the CE mark will be used during the study. The risk is limited to standard complications connected with ablation procedures.
Where is the study run from?
The study is run from the Regional Specialist Hospital, Research and Development Centre, Wroclaw (Poland).
When is the study starting and how long is it expected
The recruitment starts in March 2013. Patients will be enrolled in the study for a period of one year.
Who is the main contact?
Dr Sebastian Stec
smstec@wp.pl
Contact information
Scientific
Obroncow Tobruku 19/92
Warsaw
01-474
Poland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized prospective multicentre single-blinded active control study |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective, randomized comparison of COOL-Tip catheters vs Usual 4 mm catheters for radiofrequency ablation of accessory pathways and idiopathic ventricular arrhythmias |
| Study objectives | A COOL-Tip catheter may show better efficacy and shorter time of achievement of the procedure endpoint when used for all types and locations of ACP, ACP-T and idiopathic premature ventricular contractions (PVC) / ventricular arrhythmias (VT). |
| Ethics approval(s) | Board Name: Komisja Bioetyczna OIL Rzeszow, ul. Reformacka 10, 35-026 Rzeszow, Poland, 27/04/2012, ref: 05/2012/B |
| Health condition(s) or problem(s) studied | Accessory pathways and idiopathic ventricular arrhythmias |
| Intervention | 1:1 randomization to COOL-Tip catheters and usual 4 mm catheters for ablation. Efficacy of RFCA within 300 or 600 sec of radiofrequency energy delivery for treatment of ACP, ACP-T and idioapathic PVC/CT |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Procedural success rate; 300 sec of radiofrequency energy application; procedural success rate wtihin 300 sec of radiofrequency energy application (total ablation time <300 sec) |
| Key secondary outcome measure(s) |
1. Procedural success rate; 600 sec of radiofrequency energy application; procedural success rate within 600 sec of radiofrequency energy application (total ablation time<600 sec). |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Accessory pathway or idiopathic PVC/VT qualified for ablation 2. Electrophysiologically confirmed arrhythmia mechanism and procedure endpoint 3. Age above 18 years, either sex 4. Signed patient informed consent for participation in the study |
| Key exclusion criteria | 1. Planned AF or AFL ablation 2. Second procedure for arrhythmia 3. Acute coronary syndrome or myocardial infarction within the preceding 3 months 4. Acute reversible arrhythmia causes (such as myocarditis) 5. Advanced, haemodynamically significant valvular heart disorders 6. Status post heart valvular surgery and atrial septal defect (ASD) closure 7. Planned cardiac surgery within the upcoming 6 months 8.Inconsistent medication use within 7 days before enrolment into the study 9. Advanced heart failure [class IV according to New York Heart Association (NYHA)] 10. Lactating or pregnant women 11. Recreational drugs or alcohol addiction 12. Inability to take part in long-term observation and follow-up visits 13. Limited sanity and limited legal capacity 14. Participation in another clinical study 15. Right-sided or left-sided clots 16. Erroneous patient enrolment 17. Premature discontinuation of the ablation procedure 18. Inability to induce arrhythmia or lacking reproducible, clearly determined endpoint for Radio frequency catheter ablation (RFCA) |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- Poland
Study participating centre
01-474
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
01/09/2020: No publications found.
