NCT05922917

Brief Summary

Since a new method called pulsed-field ablation (PFA) has emerged, allowing significantly simpler, safer, and faster creation of ablative lesions in paroxysmal AF and PsAF (13), redefining the "optimal" ablation approach started to appear mandatory. Our project (The PIVCO study) aims to determine a more standardized procedure representing optimal ablation strategy for patients suffering from PsAF using PFA and multielectrode ablation catheters. The central hypothesis is that ablation of the posterior LA wall (PWI), together with mitral and cavotricuspid isthmus ablation added on top of PVI, will be associated with better effects in terms of rhythm control. Given the speed, safety, and ease of standardization of ablation using electroporation, a demonstration of the superiority of either approach could significantly impact the current standard of clinical care.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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 Progress84%
Jun 2023Nov 2026

First Submitted

Initial submission to the registry

June 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

June 20, 2023

Last Update Submit

March 16, 2026

Conditions

Persistent Atrial FibrillationPulsed-field Ablation

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrence

    The primary endpoint will be a recurrence of AF (or atrial tachycardia, AT) lasting \>30 seconds as assessed using repeated 7-day ECG Holter monitoring in patients without anti-arrhythmic drugs (AADs) during the entire post-blanking follow-up, i.e., starting three months after the index procedure. All patients should complete a 12-month follow-up period.

    1 year following ablation procedure

Secondary Outcomes (6)

  • Atrial fibrillation recurrence on AADs

    1 year following ablation procedure

  • Hospitalization rate

    1 year following ablation procedure

  • Cardioversion

    1 year following ablation procedure

  • Complications

    1 year following ablation procedure

  • Atrial Fibrillation Effect on Quality of Life (AFEQT)

    1 year following ablation procedure

  • +1 more secondary outcomes

Study Arms (2)

PVI

ACTIVE COMPARATOR

Pulmonary vein isolation

Device: pulsed-field ablation

PVI+

EXPERIMENTAL

Pulmonary vein isolation supplemented by the additional lesions: left atrial posterior wall isolation, mitral and cavotricuspid isthmus lines

Device: pulsed-field ablation

Interventions

pulsed-field ablationDEVICE

application of pulsed-field energy for pulmonary vein isolation and linear ablations

PVIPVI+

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent or long-standing persistent AF proved on at least two 12-lead ECG recordings more than one week apart or \> 7-day EKG Holter recordings
  • Age ≥ 18 years at the time of study enrollment
  • Signed informed consent

You may not qualify if:

  • Paroxysmal AF
  • Sinus rhythm on the 12-lead ECG on admission unless recent external electrical cardioversion was carried out within the last six months and the patient is treated by amiodarone
  • LA diameter \> 55 mm (measured in the parasternal long-axis view)
  • History of AF ablation in the past
  • History of cardiac surgery
  • Significant valvular defect
  • Age below 18 years
  • Pregnancy, breastfeeding
  • Any disease with a life expectancy \<1 year
  • Terminal renal failure
  • History of pacemaker or defibrillator implantation
  • Significant thyroid disease
  • Uncorrected congenital heart disease or valvular obstruction
  • Obstructive hypertrophic cardiomyopathy
  • Active myocarditis
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ceske Budejovice Hospital

České Budějovice, 37001, Czechia

Location

University Hospital

Olomouc, 77900, Czechia

Location

Institute for Clinical and Experimental Medicine

Prague, 14037, Czechia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 28, 2023

Study Start

June 20, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(3)