Concomitant PFA Bsaed PVI Plus LAAC | NCT07450755

Studies
Concomitant PFA Bsaed PVI Plus LAAC

NCT07450755

Sponsor

Asklepios proresearch

Status

Not yet recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation (AF)
Bleeding
Stroke

Interventions

Interventional LAA Closure
Pulmonary vein isolation

Countries

Not provided

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

Mar 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

Mar 1, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Feb 17, 2026

First Submission Date that Met QC Criteria

Mar 2, 2026

First Posted Date

Mar 5, 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

Mar 11, 2026

Last Update Posted Date

Mar 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Christian-Hendrik Heeger, Prof. Dr., Asklepios proresearchPrincipal Investigator

Lead Sponsor

Asklepios proresearchINDUSTRY

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific).

For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.

Detailed Description

The objective is to invite high-volume centers in Germany to submit the procedural and periprocedural data, as well as the 12-months follow-up data in a secure and standardized way. In comparison to the most registries conducted today, a dedicated database comprising a standardized questionnaire, as well as multiple data validation processes at different levels in order to assure a better data quality is used.

The aim of the COCONUT II study will collect data of a concomitant PFA based PVI and LAAC approach to treat AF and prevent bleeding and stroke within 12 months. Furthermore, economic factors could be beneficial due to only one concomitant procedure with one hospital stay instead of two procedures with two hospital stays.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Concomitant PVI plus LAAC	Experimental		Procedure: Interventional LAA Closure Procedure: Pulmonary vein isolation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interventional LAA Closure	Procedure	LAA Closure to prevent stroke and bleeding	Concomitant PVI plus LAAC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Primary safety endpoint: Major complications, (SAE) within 30 days		30 days
• Primary efficacy endpoint: Acute success of PVI and LAA closure		30 days
• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days		30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Willing to participate
Atrial fibrillation and indication for PVI (ESC guideline 2024)
Indication for OAC therapy (CHA2DS2VA score >/=2)

Exclusion Criteria:

Contraindications for PVI and / or LAA closure
Pregnancy
Previous catheter ablation for AF

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian-Hendrik Heeger, MD	Contact	0049-40-181881-8904		c.heeger@asklepios.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D006470	Hemorrhage
D020521	Stroke

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided