Substrate Guided Ablation Therapy for Atrial Fibrillation

NCT04657978 | Unknown DMC

• 1 other identifier: 263083
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial fibrillation (AF), often referred to as an 'irregular heartbeat', is the most common abnormal heart rhythm worldwide. AF may be intermittent (termed paroxysmal) or sustained (termed persistent).Catheter ablation is increasingly being used to manage individuals with AF, however in a significant proportion of cases AF recurs. Such rhythm control interventions are known to be less effective in individuals with persistent AF compared with those with paroxysmal AF. Analysis of heart tissue of individuals with AF show deposition of scar tissue within the heart muscle and this scar tissue promotes abnormal electrical activity that is involved in causing AF. The aim of the proposed study is to evaluate the feasibility and effectiveness of combining conventional pulmonary vein isolation (PVI) during catheter ablation for AF with adjunctive substrate ablation.

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Catheter Ablation; Substrate

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrhythmias (>30 seconds) after a single procedure without anti-arrhythmic drugs (AADs) within 12 months, measured by ambulatory holter monitoring

  All participants will have an ECG and ambulatory holter monitor performed at 3, 6 and 12 months after the procedure.

  12 month

Secondary Outcomes (3)

• To compare 1-year arrhythmia free clinical outcome with historical control patients matched by propensity score

  12 Months

• Safety endpoint evaluating the incidence of intraprocedural (primarily Advisor High Density Grid™ mapping catheter) related adverse events

  12 Months

• To correlate cardiac MRI derived scar distribution and burden in the left atrium with the baseline voltage map obtained using the Advisor High Density Grid™ catheter

  12 Months

Study Arms (1)

Substrate guided intervention arm

Participants recruited to the study will undergo High Density Wave Solution™ guided substrate mapping of the left atrium. Ablation will thereafter be performed to comprise wide area circumferential ablation of the pulmonary veins in pairs, followed by ablation of low voltage zones in the left atrium.

Procedure: Substrate guided left atrial ablation

Interventions

Substrate guided left atrial ablation PROCEDURE

Ablation therapy targeting areas of low voltage, which may include encirclement, homogenization or targeting of abnormal electrograms and anchored to a non-conducting structure if the region is in close proximity or likely to create an isthmus for arrhythmias.

Substrate guided intervention arm

Eligibility Criteria

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

Study Population

Participants will be recruited from patients with persistent atrial fibrillation who have been referred for catheter ablation based on standard clinical grounds.

You may qualify if:

• Patients aged ≥18 years and ≤ 80 with a clinical indication for persistent atrial fibrillation ablation

You may not qualify if:

• Contraindication to anticoagulation
• Thrombus in the left atrium despite anticoagulation
• Cerebrovascular accident within the previous 6 months
• Patients actively participating in another research study will be not be permitted to enrol. Patients who have been involved with other research studies will be able to participate after a minimum period of 3 months after completion of prior study follow up
• Females of childbearing potential must have a negative pregnancy test on the day of the ablation procedure due to the radiation exposure during the procedure

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Shouvik Haldar, FRCP MD

  Royal Brompton and Harefield Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shouvik Haldar, FRCP MD

CONTACT

01895826502; s.haldar@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share