Lesion Contiguity in Very High Power-short Duration Ablation | NCT05368610

Studies
Lesion Contiguity in Very High Power-short Duration Ablation

NCT05368610

Sponsor

University of Barcelona

Status

Unknown status

Last Update Posted

May 10, 2022Actual

Enrollment

128Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2022Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

May 5, 2022

First Submission Date that Met QC Criteria

May 5, 2022

First Posted Date

May 10, 2022Actual

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 5, 2022

Last Update Posted Date

May 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Till F. Althoff, Staff, Arrhythmia Section, Department of Cardiology, Hospital Clinic de Barcelona, University of BarcelonaPrincipal Investigator

Lead Sponsor

University of BarcelonaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Patients with paroxysmal or early persistent atrial fibrillation (AF) scheduled for pulmonary vein isolation (PVI) undergo point-by-point ablation using the QDOT micro catheter applying Qmode+ (90W over 4 seconds). All patients receive an LGE-CMR 3 months after the procedure for ablation lesion assessment. Contiguity of LGE-CMR-detected ablation lesions will be compared with a matched control group of patients that have undergone PVI accomplished by ablation index-guided ablation with 40 W following the CLOSE protocol.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Very high power-short duration ablation		PVI performed by point-by-point very high power-short duration radiofrequency ablation (QDOT-micro catheter, Biosense Webster; Qmode+; 90 W; 4 sec; target intertag distances: posterior wall 4 mm, proximity of the esophagus 5 mm, all other 3 mm)
Matched control group conventional ablation		PVI performed by conventional point-by-point radiofrequency ablation (40 W; ablation index-guided: posterior wall 350, other 450; target intertag distance 3.0 - 5.0 mm)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ablation lesion contiguity as assessed by LGE-CMR	Proportion of the circumferential ablation line covered by LGE (%)	LGE-CMR at 3 months post-ablation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

paroxysmal or early persistent (max. 3 months) atrial fibrillation
scheduled for PVI-only catheter ablation

Exclusion Criteria:

long-standing persistent atrial fibrillation
previous left atrial ablation
claustrophobia preventing CMR
sever renal insufficiency (GFR >30 ml/min)
gadolinium contrast allergy
presence of implantable devices not compatible with magnetic resonance
pregnancy and lactation

Accepts Healthy Volunteers

Not provided

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

All patients scheduled for PVI-only catheter ablation at Hospital Clinic, University of Barcelona

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Till F. Althoff, M.D.	Contact	+34932271778		althoff@clinic.cat
Lluis Mont, M.D., Ph.D.	Contact	+34932275551		LMONT@clinic.cat

Overall Officials

Name	Affiliation	Role
Till F. Althoff, M.D.	Hospital Clinic, University of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic, University of Barcelona	Recruiting	Barcelona	Catalonia	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided