A Randomized Trial of Contact Force in Atrial Flutter Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Rate of recurrent isthmus conduction
Study Overview
Brief Summary
A clinical randomized trial to evaluate if CF guided Radio Frequency Ablation (RFA) to a specific of LSI in atrial flutter i superior to standard RFA.
Detailed Description
Atrial flutter (AFL) is a macro-reentry tachycardia in the right atrium [1,2]. AFL is seen in 0,4 -1,2% of ECG´s in the hospital[3]. Prevalence is higher in patients with structural heart disease, as hypertension, coronary heart disease and cardiomyopathy and also in patients with chronic obstructive lung disease. AFL occurs frequently among patients operated for congenital heart disease.
Cavotricuspid isthmus ablation (CTIA) using radiofrequency (RF) energy is a well-established first line therapy of typical AFL.
The most common arrhythmia requiring treatment is atrial fibrillation (AF). When performing catheter ablation for AF, contact force (CF) applied during radiofrequency energy delivery is a powerful predictor of the electrical isolation of the pulmonary veins and of the clinical response. However, prospective data documenting the superiority of ablation guided by the real time CF monitoring over the standard procedure both for AF and for AFL, are missing. In this regard, showing superiority of ablation guided by the real time CF monitoring over the standard procedure in the simple lesion model of CTIA can serve as a proof of concept for more complex lesion sets, as in AF ablation. The Lesion Size Index (LSI) estimates the size of the lesion created by ablation. It takes account for the nonlinear relationship between the size of the lesion and its three main determinants (CF, power and duration [4,5]), and may therefore be an effective mean to precisely dose the amount of the delivered radiofrequency energy. This may prevent both insufficient lesion creation and complications due to excessive energy delivery. The aim of the present study is to evaluate if CF guided ablation targeting a specific value of LSI is superior to standard radiofrequency catheter ablation (RFCA).
Hypothesis:
CF guided ablation targeting a specific value of LSI is superior to standard RFCA with respect to creating lasting ablation lesions in the cavo-tricuspid isthmus region.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with typical Atrial flutter undergoing first time Cavo Tricuspid Isthmus Ablation
Exclusion Criteria
- •Congenital heart disease
- •Atrial fibrillation is the dominant arrhythmia
- •Prior right atrial atriotomy
- •Significant mitral valve disease
- •Secondary AFL (e.g. post-surgery, infections, hyperthyroidism)
- •Age < 40 years
Outcomes
Primary Outcomes
Rate of recurrent isthmus conduction
Time Frame: 3 months
Rate of recurrent isthmus conduction measured at invasive electrophysiological study 3 months after ablation
Secondary Outcomes
- Rate of recurrent isthmus conduction in the anterior, middle or posterior third of the isthmus.(3 months)
- Total procedure time(1 hour)
- Quality of Life assesing patients symptoms(12 months)
- Freedom from recurrence of Atrial flutter(3 and 12 months)
- Rate of permanent reconduction on the table(10 minutes)
- Rate of transient reconduction on the table with adenosine(10 minutes)
- Total ablation time(1 hour)
- Lesion-size-index (LSI)(1 hour)
- Occurrence of bidirectional isthmus block with the first ablation line.(1 hour)
- Ablation time needed to achieve bidirectional isthmus block(1 hour)
- Contact Force (CF)(1 hour)
- Force-time-integral (FTI)(1 hour)
- Reasons for reconduction(3 months)
Investigators
Mikkel Giehm-Reese, MD
MD
Aarhus University Hospital Skejby