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Status unknownNCT02628730PRAISEUpdated Jul 5, 2017

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

An interventional study of PVI using ThermoCool® SmartTouch® Catheter and RFA ablation data comparison in Atrial Fibrillation, sponsored by Liverpool Heart and Chest Hospital NHS Foundation Trust. Status unknown at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by Liverpool Heart and Chest Hospital NHS Foundation Trust · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The study is a prospective cohort study in 40 patients with Persistent AF. It will comprise two groups:

  1. Active Group (AI guided ablation): An initial pulmonary vein isolation (PVI) procedure will be performed guided by AI targets. All patients (regardless of AF recurrence) will undergo a repeat EP study at 8-10 weeks to identify and re-ablate site(s) of PV reconnection
  2. Historical control group (Contact Force Guided Ablation): will be formed by the 40 patients enrolled to the repeat study arm of the PRESSURE study (ClinicalTrials.gov Identifier: NCT01942408). All 40 patients underwent contact force-guided PVI followed by a repeat EP study after 8-10 weeks.

End-points

Primary outcome measure:

The proportion of patients with pulmonary vein (PV) reconnection seen at repeat EP study

Secondary outcome measures:

  • The proportion of reconnected PVs seen at repeat electrophysiology (EP) study
  • The proportion of patients maintaining freedom from atrial tachyarrhythmia for 12 months (after an initial 12 week blanking period)
  • QOL 6 and 12 months after initial ablation, as quantified by the validated atrial Fibrillation Effect on QualiTy-of-life (AFEQT) and EQ-5D-5Lquestionnaires.
  • Rates of major complications occurring within 60 days after a PVI procedure, measured in composite numbers and percentage.
02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial Fibrillation
  • Ablation
  • Pulmonary vein isolation
  • Ablation Index
03

In context

Atrial Fibrillation

3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 40 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Ablation Index Group

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

    Device: PVI using ThermoCool® SmartTouch® Catheter

  • Other
    Reference Group (Contact Force Group)

    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

  • DevicePVI using ThermoCool® SmartTouch® Catheter

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

  • DeviceRFA ablation data comparison

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: 8-10 weeks

Secondary outcomes

  1. The proportion of reconnected PVs seen at repeat EP study

    Time frame: 8-10 weeks

  2. The proportion of patients maintaining freedom from atrial fibrillation.

    Time frame: 12 months

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

    AFEQT score will be obtained as the sum of units on the questionnaire's scale.

    Time frame: 6 and 12 months

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

    EQ-5D-5L score will be obtained as the sum of units on the questionnaire's scale.

    Time frame: 6 and 12 months

  5. Major complications percent.

    Time frame: Occurring within 60 days after a PVI procedure.

07

Study locations

3 sites
  • Centro Cardiologico Monzino, IRCCS,
    Milan, 20138, Italy
  • Liverpool Heart & Chest Hospital NHS Foundation Trust
    Liverpool, L14 3PE, United Kingdom
  • Freeman Hospital
    Newcastle Upon Tyne, NE7 7DN, United Kingdom
08

References and documents

Publications

  • 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. PubMed 26108982 ↗
  • 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. PubMed 30354288 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02628730
Lead sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Dec 11, 2015
Start date
Feb 2016
Primary completion
Jan 2018 (estimated)
Completion
Jan 2018 (estimated)
Last update
Jul 5, 2017

Study contacts

Dhiraj Gupta, MD, DM, FRCP
study chair · Liverpool Heart and Chest Hospital, Liverpool, UK
Ahmed A Hussein, MRCP, MSc
principal investigator · Liverpool Heart and Chest Hospital, Liverpool, UK
Moloy Das
principal investigator · Freeman Hospital, Newcastle, UK
Antonio D Russo
principal investigator · Centro Cardiologico Monzino

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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