Investigating the safety and efficacy outcomes of high power and short duration ablation for atrial fibrillation in comparison with current standard of lower power and longer duration ablatio

Not Applicable

Completed

• Conditions: Atrial fibrillation; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12619001603101
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-21
• Study Completion: 2022-05-24
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.Patients aged more than / equal to 18 years old
2.Patients undergoing a first-time ablation procedure for AF
3.Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication
4.Patients must be able and willing to provide written informed consent to participate in this investigation
5.Patients must be willing and able to comply with all peri-ablation and follow- up requirements

Exclusion Criteria

1.Patients with long-standing persistent AF - defined as a sustained episode lasting more than 3 years
2.Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
3.Patients with AF felt to be secondary to an obvious reversible cause
4.Left atrium thrombus
5.Previous AF ablation
6.Severe valvular heart disease
7.Known esophageal disorder / GORD
8.Patients with contraindications for taking anticoagulation therapy
9.Patients with creatinine >200 ml/min or end stage renal / liver impairment
10.Pregnancy
11.Diagnosis of hypertrophic cardiomyopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Esophageal thermal injury [24 hours following intervention through routine post ablation endoscopy ];Significant intraluminal temperature rise during ablation, defined as : <br>oNumber of temperature spikes more than or equal to 39ºC<br>oNumber of steep temperature rises of more than 0.5 -1 degrees within 5 seconds<br>oNumber of steep temperature rises of more than 1 degrees within 5 seconds<br>oCumulative amount of time in which temperature was more than or equal to 38ºC<br><br>Intraluminal temperature is measured using a multisensor temperature probe ( S -Cath, Circa Scientific) placed in the esophagus [Intraprocedural]