Pulmonary Vein Reconnection Following Ablation Index-guided Ablation: a Success Evaluation

NCT02628730 | Unknown

• 2 other identifiers: BWI-IIS-386NHS REC
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief Summary

Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart. Tablets to try to normalise the heart rhythm rarely work well. As a result, doctors have devised a treatment called catheter ablation in which special wires are used to deliver heat energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many patients (almost 1 in 2), some of these ablation lesions recover, and this leads to AF recurrence. Many of these patients then need a second procedure to deliver further ablation at these recovered areas. Recent research has shown that monitoring of heat delivery with a factor called Ablation Index may be useful in predicting which ablation lesions are less likely to recover. Therefore, we aim to carry out AF ablation guided with Ablation Index (AI) and observe whether this will be associated with better durability of ablation lesions, and thereby better freedom from AF. This study will include patients with persistent AF, those whose AF episode(s) last for longer than seven days. All patients participating in the study will undergo an initial ablation treatment guided by ablation Index . All patients will undergo a repeat procedure 8-10 weeks after their initial treatment. Any gaps found during the second procedure will be closed again by delivery of ablation. All participants will be issued with a simple to use handheld heart rhythm monitor, and asked to make a 30-second recording of their heart rhythm each day and also whenever they have symptoms. The monitor stores these recordings and they will be downloaded at review appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation procedure.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Ablation; Pulmonary vein isolation; Ablation Index

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with PV reconnection seen at repeat EP study

  8-10 weeks

Secondary Outcomes (5)

• The proportion of reconnected PVs seen at repeat EP study

  8-10 weeks

• The proportion of patients maintaining freedom from atrial fibrillation.

  12 months

• Quality of Life (QOL) using score of AFEQT Questionnaire.

  6 and 12 months

• QOL using score of EQ-5D-5L Questionnaire.

  6 and 12 months

• Major complications percent.

  Occurring within 60 days after a PVI procedure.

Study Arms (2)

Ablation Index Group

ACTIVE COMPARATOR

PVI using radiofrequency ablation (RFA) guided by Ablation Index.

Device: PVI using ThermoCool® SmartTouch® Catheter

Reference Group (Contact Force Group)

OTHER

That group will be formed by the 40 patients who underwent mandatory repeat EPS 8-10 weeks following contact force guided PVI in the PRESSURE study (ClinicalTrials.gov Identifier: NCT01942408). RFA ablation data from reference group (Contact Force Group) will be compared with those obtained from the Ablation Index Group.

Device: RFA ablation data comparison

Interventions

PVI using ThermoCool® SmartTouch® Catheter DEVICE

PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index.

Ablation Index Group

RFA ablation data comparison DEVICE

Ablation data from previous ablations, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), that members of this group had in the past, will be compared with those of the Active Comparator Group.

Reference Group (Contact Force Group)

Eligibility Criteria

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

You may qualify if:

• Aged over 18 years
• Persistent AF (defined, according to the ESC/EHRA Guidelines for the Management of Atrial Fibrillation 2010, as AF episode that either lasts longer than 7 days or requires termination by cardioversion, either with drugs or by direct current cardioversion (DCC) ).
• Symptomatic in spite of drug treatment
• Due to undergo pulmonary vein isolation by RF ablation

You may not qualify if:

• Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA) or non-VKA (NOAC) agent
• Previous catheter or surgical ablation procedure for AF
• Unwillingness or inability to complete the required follow-up arrangements
• Current pattern of paroxysmal AF
• Long standing persistent AF (continuous AF longer than 12 months before ablation)
• Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
• Known infiltrative cardiomyopathy
• Known severe left ventricular systolic function (ejection fraction \<35%)
• Pregnancy

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Biosense Webster, Inc.: collaborator

Study Sites (3)

Centro Cardiologico Monzino, IRCCS,

Milan, 20138, Italy

Location

Liverpool Heart & Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (2)

• Das M, Wynn GJ, Morgan M, Lodge B, Waktare JE, Todd DM, Hall MC, Snowdon RL, Modi S, Gupta D. Recurrence of atrial tachyarrhythmia during the second month of the blanking period is associated with more extensive pulmonary vein reconnection at repeat electrophysiology study. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):846-52. doi: 10.1161/CIRCEP.115.003095. Epub 2015 Jun 24.

  PMID: 26108982 BACKGROUND

• Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.

  PMID: 30354288 DERIVED

Related Links

• The Effect of Early Repeat Atrial Fibrillation (AF) Ablation on AF Recurrence (PRESSURE) Study

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Dhiraj Gupta, MD, DM, FRCP

  Liverpool Heart and Chest Hospital, Liverpool, UK

  STUDY CHAIR

• Ahmed A Hussein, MRCP, MSc

  Liverpool Heart and Chest Hospital, Liverpool, UK

  PRINCIPAL INVESTIGATOR

• Moloy Das

  Freeman Hospital, Newcastle, UK

  PRINCIPAL INVESTIGATOR

• Antonio D Russo

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: December 11, 2015
• Study Start: February 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

GB (2); IT (1)