The RIPPLE AT-PLUS Study

Liverpool Heart and Chest Hospital NHS Foundation Trust

Status: Not yet enrolling

Conditions: Atrial Tachycardia

Treatments: Procedure: Catheter ablation of atrial tachycardia: Ripple Mapping guided.; Procedure: Catheter ablation of atrial tachycardia: Conventional mapping guided.

Study type: Interventional

Funder types: Other

Identifiers

NCT03915691

19SM5013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Isthmus targeted approach using Ripple Mapping

Active Comparator group

Description:

Intervention: Isthmus targeted approach using Ripple Mapping catheter ablation of atrial tachycardia.

Treatment:

Procedure: Catheter ablation of atrial tachycardia: Ripple Mapping guided.

Conventional Mapping

Active Comparator group

Description:

Intervention: conventional catheter ablation of atrial tachycardia.

Treatment:

Procedure: Catheter ablation of atrial tachycardia: Conventional mapping guided.