Individualised Mapping in Persistent AF Ablation (IMAGE AF)

September 22, 2021 updated by: Royal Brompton & Harefield NHS Foundation Trust

Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation

A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 18 years old
  2. Signed informed consent.
  3. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
  4. In atrial fibrillation at the time of the index procedure.

Exclusion Criteria:

  1. Paroxysmal atrial fibrillation.
  2. Previous ablation procedure for atrial fibrillation.
  3. Left ventricular ejection fraction < 45%
  4. Obesity with BMI > 35 kg/m2
  5. Congenital heart disease.
  6. Previous cardiac surgery with atriotomy.
  7. Previous left atrial appendage closure/ligation.
  8. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
  9. Pregnancy
  10. Current enrolment in a study evaluating another device or drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PVI only
Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF.
Procedure: Pulmonary veins isolation
Wide area circumferential pulmonary veins isolation
Experimental: PVI + IM
Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF.
Procedure: Pulmonary veins isolation + Cartofinder-guided ablation
The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from atrial arrhythmia
Time Frame: 12 monts
Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs
12 monts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from atrial fibrillation
Time Frame: 12 months
Freedom from atrial fibrillation without the use of antiarrhythmic drugs
12 months
Atrial fibrillation burden reduction
Time Frame: 12 months
Reduction of the atrial fibrillation burden by 75% compared to baseline
12 months
Absolute atrial fibrillation burden
Time Frame: 12 months
Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Investigators

  • Study Director: Vias Markides, MD, FESC, Royal Brompton Hospital, London, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Persistent Atrial Fibrillation

Clinical Trials on Pulmonary veins isolation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe