Evidence map›Paper›PMID 37309845›Full record

ArticleClinical cardiology2023

A randomized sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM-PVI study): Study design and rationale.

Rajdip Dulai, Stephen S Furniss, Neil Sulke, Nick Freemantle, Pier D Lambiase, David Farwell, Neil T Srinivasan, Stuart Tan, Nikhil Patel, Adam Graham and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04272762 (A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04272762 nacompletednot on this map

A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (The SHAM-PVI Study)

TypeinterventionalSponsorEast Sussex Hospitals NHS TrustRan2020 to 2024Enrolled140ConditionsAtrial FibrillationArmsCryoablation, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 2 countries.

Rajdip DulaiCardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, East Sussex, UK.ORCID http://orcid.org/0000-0003-1583-2494
Stephen S Furniss
Neil SulkeCVS Healthcare Ltd., Eastbourne, UK.
Nick FreemantleInstitute for Clinical Trials and Methodology, University College London, London, UK.
Pier D LambiaseInstitute of Cardiovascular Science, University College of London, London, UK.
David FarwellMid and South Essex NHS Foundation Trust, The Essex Cardiothoracic Centre, Essex, UK.
Neil T SrinivasanMid and South Essex NHS Foundation Trust, The Essex Cardiothoracic Centre, Essex, UK.
Stuart TanMid and South Essex NHS Foundation Trust, The Essex Cardiothoracic Centre, Essex, UK.
Nikhil PatelCardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, East Sussex, UK.
Adam GrahamNottingham University Hospital NHS Trust, Nottingham, UK.
Rick A VeaseyCardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, East Sussex, UK.
Eastbourne District General Hospital · GBSouth Essex Partnership University Foundation NHS Trust · GBEast Sussex Healthcare NHS Trust · GBMay Institute · USMRC Clinical Trials Unit at UCL · GBNottingham University Hospitals NHS Trust · GBThe London College · GB

Funding

Eastbourne Cardiology Research Charity FundMedtronic
6 · The paper itself

Abstract

introductionPulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. HYPOTHESIS &

methodsThe objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM-PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures.

resultsEnrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024.

conclusionThis study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden.

Indexed as

Atrial FibrillationCatheter AblationCryosurgeryPulmonary VeinsDouble-Blind MethodHeart AtriaHumansRandomized Controlled Trials as TopicRecurrenceTreatment Outcomeablationatrial fibrillationcatheter ablationcryoablationplacebopulmonary vein isolationsham

Identifiers

PMID37309845
PMCPMC10436780
OpenAlexW4380423208

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.