Randomised Comparison of the Octaray and Pentaray Catheters

NCT05988424 | Unknown DMC

• 1 other identifier: RHM CAR0638
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study we aim to compare the mapping performance in the left atrium of the established Pentaray catheter to the newer Octaray catheter.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; ablation; mapping

Outcome Measures

Primary Outcomes (1)

• Time to collect left atrial geometry

  Time to collect left atrial geometry

  1 year

Secondary Outcomes (5)

• Volume of LA geometry

  1 year

• Map point density

  1 year

• Time to start point collection, based on fulfilment of TPI criteria

  1 year

• Low voltage area comparison

  1 year

• Number and size of PVI gaps identified

  1 year

Study Arms (2)

Pentaray

ACTIVE COMPARATOR

Initial map collected with Pentaray

Other: Left atrial mapping

Octaray

ACTIVE COMPARATOR

Initial map collected with Octaray

Other: Left atrial mapping

Interventions

Left atrial mapping OTHER

Creation of a left atrial voltage map

Octaray; Pentaray

Eligibility Criteria

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

You may qualify if:

• Patients \>18 years listed for redo AF ablation on clinical grounds GA or LA/sedation cases

You may not qualify if:

• Age \<18 years Pregnancy Unable or unwilling to consent Mechanical mitral valve Replacement Enrolled in another clinical study that could confound the results of this study (note: patients enrolled in complementary study are eligible for enrolment)

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Biosense Webster, Inc.: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Waqas Ullah

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waqas Ullah

CONTACT

+442381208128; waqas.ullah@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will not be aware which mapping catheter they are randomised to have used in their case first. The data will be processed for analysis blinded to the catheter used to collect the map
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover from one mapping catheter to the other with randomisation as to which catheter is used first

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share