Comparison of COOL-Tip catheters vs Usual 4 mm catheters for radiofrequency ablation of accessory pathways and idiopathic ventricular arrhythmias

A prospective, randomized comparison of COOL-Tip catheters vs Usual 4 mm catheters for radiofrequency ablation of accessory pathways and idiopathic ventricular arrhythmias

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN06594397

Enrollment

200

Registered

2013-05-16

Start date

2013-03-01

Completion date

Unknown

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accessory pathways and idiopathic ventricular arrhythmias Circulatory System Ventricular fibrillation and flutter

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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) 2. Need for cross-over; 300 sec radiofrequency energy applications with suboptimal power or impedance or after 600 sec of failed radiofrequency energy application with optimal parameters of mapping and RF energy supply; need for additional use of COOL-Tip catheter (in usual 4 mm tip group) or additional COOL-Tip catheter in COOL-Tip group	—

Measure

Time frame

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) 2. Need for cross-over; 300 sec radiofrequency energy applications with suboptimal power or impedance or after 600 sec of failed radiofrequency energy application with optimal parameters of mapping and RF energy supply; need for additional use of COOL-Tip catheter (in usual 4 mm tip group) or additional COOL-Tip catheter in COOL-Tip group

—

Secondary

Measure	Time frame
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). 2. Cumulative duration of ablation energy delivery (sec); periprocedural 3. RF ablation time (sec); periprocedural 4. Duration of fluoroscopic exposure (min); periprocedural 5. Procedural duration (min); periprocedural 6. Early procedural complication rate within 24 hours after procedure 7. Late camplication rate 24 hours to 12 months after procedure	—

Measure

Time frame

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). 2. Cumulative duration of ablation energy delivery (sec); periprocedural 3. RF ablation time (sec); periprocedural 4. Duration of fluoroscopic exposure (min); periprocedural 5. Procedural duration (min); periprocedural 6. Early procedural complication rate within 24 hours after procedure 7. Late camplication rate 24 hours to 12 months after procedure

—

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026