Clinical trial NCT03915691: The RIPPLE AT-PLUS Study
Official title: Isthmus Guided vs Anatomical Linear Ablation in the Treatment of Scar Related Atrial Tachycardia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Tachycardia
Keywords: Atrial Tachycardia
Atrial Fibrillation
Mapping
Ablation
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Imperial College Healthcare NHS Trust
First posted: 2019-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atrial tachycardia is a symptomatic arrhythmia, for which an effective treatment is a catheter ablation procedure. The goal of the Ripple AT-Plus study is to evaluate two methods of performing catheter ablation for atrial tachycardia. The main outcome assessed during the study is long-term recurrence of atrial tachycardia following the catheter ablation procedure.

Detailed description: Catheter based mapping of the electrical signals in the heart during atrial tachycardia can identify areas that require ablation in order to treat the arrhythmia. There are numerous methods by which to map atrial tachycardia. Isthmus guided ablation using Ripple Mapping is one such method, and has recently been demonstrated to improve diagnostic accuracy of mapping and therefore improve acute procedural outcomes (termination of the tachycardia).

However, it is not known if improved acute procedural outcomes translate into long-term benefits for patients. At present, the recurrence rate following atrial tachycardia ablation is near 30%. We hypothesise that isthmus guided ablation using Ripple Mapping can reduce long-term recurrence following ablation as improved diagnostic accuracy of mapping can lead to more targeted, less extensive, ablation.

Patients referred for catheter ablation of atrial tachycardia will be randomised to undergo the procedure by isthmus targeted approach using Ripple Mapping or conventional approach using local activation time. Otherwise, the catheters used to perform the mapping and ablation will be the same in both groups. After the procedure, follow up will occur at 1 year with a further Holter Montior. Any arrhythmia recurrence will be documented and the two arms will be compared for acute success, 12 month success, ablation required and procedure time.

Eligibility criteria: Inclusion Criteria:

1. Referred for catheter ablation of AT by the direct care team, based on clinical indication.
2. Male or female, aged \>18 years old.
3. Able to consent for recruitment to the trial and the catheter ablation procedure.

Exclusion Criteria:

1. Contraindication to catheter ablation as deemed by the clinical team.
2. Typical atrial flutter or AF on ECG.

Primary outcomes:
measure: Atrial arrhythmia recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Acute success during the catheter ablation procedure by the first ablation set.
timeFrame: Procedure.
measure: Acute success during the catheter ablation procedure without the need of entrainment.
timeFrame: Procedure.
measure: Procedure failure.
timeFrame: Procedure.
measure: Total procedure time.
timeFrame: Procedure.
measure: Ablation required
timeFrame: Procedure.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Liverpool Heart & Chest Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Newcastle
country: United Kingdom
facility: Freeman Hospital, The Newcastle Upon Tyne NHS Foundation Trust
Study officials:
affiliation: Liverpool Heart & Chest Hospital
name: Vishal Luther, MBBS
role: PRINCIPAL_INVESTIGATOR
References: