search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cryoablation
Placebo
Sponsored by
East Sussex Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Ablation, Cryoablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic CentreRecruiting
  • Eastbourne District General HospitalRecruiting
  • Conquest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ablation

Placebo

Arm Description

pulmonary vein isolation

placebo procedure

Outcomes

Primary Outcome Measures

Atrial fibrillation burden using continuous monitoring

Secondary Outcome Measures

Time to symptomatic atrial tachyarrhythmia stratified by length of episode
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode
Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode
Change in AF specific quality of life score between each group (AF-PROMS)
Change in health related quality of life in each group (36-Item Short Form Survey Instrument )
Comparison of medical treatment ( Antiarrhythmic drug use)
Comparison of unscheduled use of health care services
Number of procedure related complications / adverse events

Full Information

First Posted
February 12, 2020
Last Updated
June 13, 2023
Sponsor
East Sussex Hospitals NHS Trust
Collaborators
Eastbourne Cardiology Research Charity Fund, Medtronic
search

1. Study Identification

Unique Protocol Identification Number
NCT04272762
Brief Title
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation
Acronym
SHAM-PVI
Official Title
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (The SHAM-PVI Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Sussex Hospitals NHS Trust
Collaborators
Eastbourne Cardiology Research Charity Fund, Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Ablation, Cryoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablation
Arm Type
Active Comparator
Arm Description
pulmonary vein isolation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo procedure
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
Pulmonary vein isolation with cryoablation
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Placebo procedure
Primary Outcome Measure Information:
Title
Atrial fibrillation burden using continuous monitoring
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to symptomatic atrial tachyarrhythmia stratified by length of episode
Time Frame
6 months
Title
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode
Time Frame
6 months
Title
Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode
Time Frame
6 months
Title
Change in AF specific quality of life score between each group (AF-PROMS)
Time Frame
Baseline and 6 months
Title
Change in health related quality of life in each group (36-Item Short Form Survey Instrument )
Time Frame
Baseline and 6 months
Title
Comparison of medical treatment ( Antiarrhythmic drug use)
Time Frame
6 months
Title
Comparison of unscheduled use of health care services
Time Frame
6 months
Title
Number of procedure related complications / adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rick Veasey
Phone
0300 131 4500
Ext
4132
Email
rick.veasey@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Rajdip Dulai
Phone
0300 131 4500
Ext
4132
Email
rajdip.dulai@nhs.net
Facility Information:
Facility Name
Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre
City
Basildon
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Farwell
Email
david.farwell@nhs.net
Facility Name
Eastbourne District General Hospital
City
Eastbourne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rick Veasey
Email
rick.veasey@nhs.net
Facility Name
Conquest Hospital
City
St Leonards-on-Sea
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajdip Dulai
Email
rajdip.dulai@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37309845
Citation
Dulai R, Furniss SS, Sulke N, Freemantle N, Lambiase PD, Farwell D, Srinivasan NT, Tan S, Patel N, Graham A, Veasey RA. A randomized sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM-PVI study): Study design and rationale. Clin Cardiol. 2023 Aug;46(8):973-980. doi: 10.1002/clc.24066. Epub 2023 Jun 13.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs