A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-23

Study Completion Date

2024-03-04

Brief Summary

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This is a double blinded randomised placebo-controlled trial comparing the effects of catheter ablation (Cryoablation) versus a placebo procedure on atrial fibrillation burden, symptoms and quality of life

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ablation

pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

Cryoablation

Intervention Type PROCEDURE

Pulmonary vein isolation with cryoablation

Placebo

placebo procedure

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

Placebo procedure

Interventions

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Cryoablation

Pulmonary vein isolation with cryoablation

Intervention Type PROCEDURE

Placebo

Placebo procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18 years
* Symptomatic paroxysmal or persistent atrial fibrillation despite at least one antiarrhythmic drug (AAD Type I or III, β-blocker or AAD intolerance).
* Referred for catheter ablation

Exclusion Criteria

* Long term persistent AF (continuous episode lasting more than 1)
* Prior left atrium catheter or surgical atrial fibrillation ablation
* Patients with other arrhythmias requiring ablative therapy
* Left atrium (LA) ≥5.5 cm
* Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.
* Awaiting cardiac surgery or PCI
* Myocardial infarction within three months prior to enrolment.
* Stroke or transient ischemic attack (TIA) within three months prior to enrolment
* Unstable angina
* Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
* Any condition contraindicating chronic anticoagulation
* Any untreated or uncontrolled hyperthyroidism or hypothyroidism
* Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) \< 15 ml / min)
* Patients with metallic prosthetic valves
* Pregnant or breastfeeding women
* Medical conditions limiting expected survival to \<1 year
* History of claustrophobia or panic attacks
* Left ventricular ejection fraction (LVEF) less than 35%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No