Low-VOLTage Area-Guided Catheter Ablation and SVC Isolati... | NCT07587541

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2026Estimated

Primary Completion Date

Nov 1, 2029Estimated

Completion Date

Nov 1, 2029Estimated

First Submitted Date

May 7, 2026

First Submission Date that Met QC Criteria

May 7, 2026

First Posted Date

May 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to determine whether low-voltage areas (LVA)-guided catheter ablation combined with superior vena cava (SVC) isolation and pulmonary vein isolation (PVI), performed using the balloon-in-basket Volt™ pulsed field ablation PFA system, is superior to PVI alone using same technology in reducing arrhythmia recurrence at 6 and 12 months in patients with persistent AF and detectable significant LVAs on three-dimensional electroanatomical mapping.

Moreover, the study will investigate, in a separate randomized cohort, the effect of adding SVC isolation to PVI using the balloon-in-basket Volt™ PFA system, compared with PVI alone, in patients with persistent AF without detectable significant LVAs during three-dimensional electroanatomical mapping.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

618Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
LVA-guided catheter ablation combined with SVC isolation and PVI	Experimental	Device: Volt™ Pulsed Field Ablation System
LVA-guided catheter ablation combined with PVI alone	Active Comparator	Device: Volt™ Pulsed Field Ablation System
SVC isolation and PVI in patients without detectable significant LVA	Experimental	Device: Volt™ Pulsed Field Ablation System
PVI alone in patients without detectable significant LVA	Active Comparator	Device: Volt™ Pulsed Field Ablation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Volt™ Pulsed Field Ablation System	Device	SVC isolation	LVA-guided catheter ablation combined with SVC isolation and PVI SVC isolation and PVI in patients without detectable significant LVA

Measure	Description	Time Frame
Recurrence of atrial arrhythmias defined as atrial fibrillation, atrial flutter or atrial tachycardia lasting ≥30 seconds occurring after a 2-month post-procedural blanking period.		within 6 months following catheter ablation.

Eligibility Module

Eligibility Criteria

Inclusion criteria

Participants must meet all the following criteria:

Age ≥18 years
Persistent AF, defined as continuous AF lasting at least 7 days
Indication for catheter ablation according to the latest ESC guidelines
Written informed consent

Exclusion criteria

Participants will be excluded if any of the following criteria apply:

Inability or unwillingness to provide informed consent
Continuous AF duration duration of ≥2 years
Documented atrial tachycardia or atrial flutter
Previous left atrial catheter ablation or cardiac surgery
Planned cardiac surgery within the first 3 months after inclusion
History of heart transplantation, current listing for transplantation, or planned cardiac assist device implantation
Severe mitral or aortic valvular disease, according to the ESC guidelines
Platelet count <50,000 cells/mm³
Body mass index >45 kg/m² or <18 kg/m²
Untreated thyroid dysfunction (patients may be included once hypothyroidism or hyperthyroidism is adequately treated)
Absolute contraindication to oral anticoagulation
Any comorbidity that limits life expectancy to <1 year
Active systemic infection (enrolment permitted after successful treatment)
Women who are pregnant or breastfeeding
Women of childbearing potential not using highly effective contraception (PEARL Index <1%)
End-stage renal disease (GFR <15 ml/min/1.73 m2) or hepatic failure (Child Pugh C)
Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV
Participation in another randomized controlled trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms