NCT04272762

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

4.1 years

First QC Date

February 12, 2020

Last Update Submit

March 12, 2024

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationAblationCryoablation

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation burden using continuous monitoring

    6 months

Secondary Outcomes (8)

  • Time to symptomatic atrial tachyarrhythmia stratified by length of episode

    6 months

  • Time to asymptomatic atrial tachyarrhythmia stratified by length of episode

    6 months

  • Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode

    6 months

  • Change in AF specific quality of life score between each group (AF-PROMS)

    Baseline and 6 months

  • Change in health related quality of life in each group (36-Item Short Form Survey Instrument )

    Baseline and 6 months

  • +3 more secondary outcomes

Study Arms (2)

Ablation

ACTIVE COMPARATOR

pulmonary vein isolation

Procedure: Cryoablation

Placebo

PLACEBO COMPARATOR

placebo procedure

Procedure: Placebo

Interventions

CryoablationPROCEDURE

Pulmonary vein isolation with cryoablation

Ablation
PlaceboPROCEDURE

Placebo procedure

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre

Basildon, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, United Kingdom

Location

Conquest Hospital

Saint Leonards-on-Sea, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 37309845BACKGROUND

  • Dulai R, Sulke N, Freemantle N, Lambiase PD, Farwell D, Srinivasan NT, Tan S, Patel N, Graham A, Veasey RA. Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial. JAMA. 2024 Sep 2;332(14):1165-73. doi: 10.1001/jama.2024.17921. Online ahead of print.

    PMID: 39221629DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

January 23, 2020

Primary Completion

March 4, 2024

Study Completion

March 4, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)