AV Node Isolation in Atrial Fibrillation vs. Modulation b... | NCT04859933

Studies
AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy

NCT04859933

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Status

Completed

Last Update Posted

Aug 9, 2022Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Atrial Fibrillation
AV Node Ablation
Escape; Rhythm

Interventions

AV-node isolation
AV-node ablation

Countries

Germany

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Feb 28, 2022Actual

Completion Date

Feb 28, 2022Actual

First Submitted Date

Apr 22, 2021

First Submission Date that Met QC Criteria

Apr 22, 2021

First Posted Date

Apr 26, 2021Actual

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

Aug 8, 2022

Last Update Posted Date

Aug 9, 2022Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects. The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent preservation and higher rate of escape rhythm compared to AVNA. This retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40 historical AVNA-controls. Among others these two methods were compared regarding escape rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area product (DAP).

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AVNA group		Group of historical controls beeing treated with AV-node ablation	Procedure: AV-node ablation
AVNI group		Inculudes all patients beeing treated with AV-node isolation	Procedure: AV-node isolation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AV-node isolation	Procedure	Abaltion performed in the right atrium isolating the AV-node from the atrium	AVNI group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AV-node escape rhythm		intraoperative, follow-up after 1 to 3 month
bundle branch blocks		intraoperative, follow-up after 1 to 3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA

Exclusion Criteria:

other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to Heart- and Diabetes Centre NRW for AV-node ablation/isolation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum		Bad Oeynhausen		32545	Germany

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided