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

NCT01942408 | Completed DMC

• 2 other identifiers: LHCH967BWI-IIS-0239
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart and causes an irregular and often rapid heartbeat. Developing this condition may cause significant health problems and symptoms that affect normal day-to-day activities. Patients with AF also have a shorter life expectancy on average. Tablets used to try to normalise the heart rhythm rarely work well. As a result, doctors have devised a treatment to try to cure this condition. Special wires (called catheters) are used to deliver heat energy (called ablation) on the inside surface of the heart. This technique has been used more and more in recent years for patients with troublesome symptoms due to AF. The aim of the treatment is to draw lines of ablation in specific places in the heart. Unfortunately, a lot of patients (almost 50%) get AF again after this treatment and most of these patients have a second treatment performed. It is usually found at this second treatment that gaps have developed in the lines of ablation that were drawn the first time around. The investigators think that electively doing a second treatment to close these gaps a couple of months after the first treatment may mean that fewer of these patients will get AF again in the future. The investigators also want to find out what factors make a line of ablation less likely to develop gaps. In this study, participants will be assigned to one of two groups:

1. 1.a "standard care" group, who will have a single treatment initially.
2. 2.a "repeat study" group, who will have the initial treatment followed by a second treatment 8-10 weeks later.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Pulmonary vein isolation; Pulmonary vein reconnection

Outcome Measures

Primary Outcomes (1)

• Atrial tachyarrhythmia (AT) recurrence

  The proportion of patients maintaining freedom from AT for 12 months post-initial PVI (after an initial 12 week blanking period)

  12 months post-initial pulmonary vein isolation (PVI)

Secondary Outcomes (3)

• Quality of life measures

  12 months post-initial PVI

• Time to recurrence

  12 months post-initial PVI

• Comparison of major complication rates

  4 months post-initial PVI

Other Outcomes (2)

• Pulmonary vein (PV) reconnection in patients with and without early recurrence

  3 months post-initial PVI

• Correlation between Visitag data and sites of PV reconnection

  4 months post-inital PVI

Study Arms (2)

Standard care group

NO INTERVENTION

Patients will undergo an initial PVI procedure. Further management will be determined by AF recurrences at the responsible Consultant's discretion as per standard care.

Repeat study group

ACTIVE COMPARATOR

Following an initial PVI procedure, all patients (regardless of early AF recurrence) will undergo a repeat electrophysiology (EP) study at 8-10 weeks post-initial PVI, with repeat PVI of any PV reconnection identified

Procedure: Repeat PVI

Interventions

Repeat PVI PROCEDURE

Repeat EP study 8-10 weeks post-initial PVI with re-isolation of PV reconnection

Repeat study 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
• Current pattern of paroxysmal AF (defined as electrocardiogram (ECG)-proven episodes of AF which are self-limiting and last less than 7 days on each occasion, or which were cardioverted electrically or pharmacologically less than 48 hours from onset)
• Due to undergo pulmonary vein isolation by radiofrequency (RF) ablation

You may not qualify if:

• Inability or unwillingness to receive oral anticoagulation with warfarin or alternative anticoagulant drug
• Previous ablation procedure for AF
• Unwillingness or inability to complete the required follow-up arrangements
• Current pattern of persistent (episodes of AF which last longer than 7 days or which last longer than 48 hours but require electrical or pharmacological cardioversion) or permanent AF
• Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
• Reversible cause for AF
• 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 (1)

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

Related Publications (1)

• Das M, Wynn GJ, Saeed Y, Gomes S, Morgan M, Ronayne C, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Pulmonary Vein Re-Isolation as a Routine Strategy Regardless of Symptoms: The PRESSURE Randomized Controlled Trial. JACC Clin Electrophysiol. 2017 Jun;3(6):602-611. doi: 10.1016/j.jacep.2017.01.016. Epub 2017 Mar 29.

  PMID: 29759434 DERIVED

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, DM, MD, FRCP

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 16, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

GB (1)