Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation

NCT02917044 | Terminated

• 1 other identifier: 15HH2466
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicentre, randomized single blind, parallel group study to be conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40 eligible for randomization. The study is designed to compare the operator's best attempt at WACA completion with and without Rhythmia guidance

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Total time in minutes required to produce isolation of veins per WACA

  Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total RF time taken to isolate the veins for that WACA will be measured as one of 2 joint primary outcome measures.

  Procedural - i.e. assessed over procedure duration only (about 3 hours)

• Total number of radiofrequency ablation lesions to produce isolation of veins per WACA

  Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total number of lesions (each lesion being 30s in duration) to isolate the veins for that WACA will be measured as one of two joint primary outcome measures.

  Procedural - i.e. assessed over procedure duration only (about 3 hours)

Secondary Outcomes (8)

• Whether ostial ablation is required in each case (Yes/No)

  Procedural - i.e. assessed over procedure duration only (about 3 hours)

• Number of radiofrequency ablation lesions required within the WACA lesion set

  Procedural - i.e. assessed over procedure duration only (about 3 hours)

• Total radiofrequency ablation time (in mins) within the WACA lesion set

  Procedural - i.e. assessed over procedure duration only (about 3 hours)

• Total number of radiofrequency ablation lesions required to produce PV isolation per patient

  Procedural - i.e. assessed over procedure duration only (about 3 hours)

• Total procedural time (in mins) required to produce PV isolation

  Procedural - i.e. assessed over procedure duration only (about 3 hours)

Study Arms (2)

Group A - Standard Care

ACTIVE COMPARATOR

The operator will attempt to complete the WACA lesion set using standard techniques. These include ablating any obvious gaps in the lesion set, ablating at the WACA line in a location radial to the earliest PV signal measured by the Orion catheter situated within the PV, and guided by amplitude and dV/dt of signals along the WACA lesion set measured using the mapping catheter. If this fails the operator will resort to OSA as per their usual practice.

Procedure: Atrial Fibrillation Ablation; Device: Catheters used to isolate pulmonary veins

Group B - Rhythmia mapping

EXPERIMENTAL

The operator will form Rhythmia maps focussing on the region of the WACA line surrounding the non-isolated vein(s) whilst pacing from CS. This will be used as a means of targeting RF ablation to gaps in the WACA line (in addition to use of standard observation of signals as per group A). If this fails then the operator will resort to OSA as per their usual practice.

Device: Catheters used to isolate pulmonary veins; Procedure: Atrial Fibrillation Ablation with HD mapping to isolate PVs; Device: Rhythmia HD mapping

Interventions

Atrial Fibrillation Ablation PROCEDURE

Procedure involving catheter ablation to produce pulmonary vein isolation. Pulmonary veins are isolated by assessing electrograms circumferentially around the PV using the Orion catheter.

Group A - Standard Care

Catheters used to isolate pulmonary veins DEVICE

Catheters transiently inserted into body via femoral veins in order to produce pulmonary vein isolation. These catheters are the same in each arm and comprise the Orion catheter (Boston Scientific) and the Tacticath (St Jude) which are used to produce pulmonary vein isolation and which are approved for use in standard EP procedures by the relevant authorities (CE marked). It is merely the protocol by which they are used that iffers in the two arms.

Group A - Standard Care; Group B - Rhythmia mapping

Atrial Fibrillation Ablation with HD mapping to isolate PVs PROCEDURE

Procedure involving catheter ablation to produce pulmonary vein isolation. Pulmonary veins are isolated by use of electroanatomical mapping with the Orion catheter around the sites ablation in order to target points of breakthrough.

Group B - Rhythmia mapping

Rhythmia HD mapping DEVICE

Mapping activation patterns using the Rhythmia system in conjunction with the Orion catheter

Group B - Rhythmia mapping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECG documented AF
• Listed for AF ablation by referring physician
• Planned ablation includes a first-time PVI.
• Patient signed informed consent form

You may not qualify if:

• Age \<18 or \>80
• LA diameter \>60mm
• AF secondary to transient correctible abnormalits (e.g. electrolyte imbalance, thyrotoxicosis, recent infective or inflammatory process)
• Intra-atrial thrombus or tumour
• Renal failure requiring haemodialysis
• Heart failure with NYHA III-IV or EF\<35%

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Hammersmith Hospital

London, Please Select Region, State Or Province, W120HS, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boon Lim

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: September 28, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)