Electrically Guided Bachmann's Bundle Pacing: A Lead Plac... | NCT05153291

Studies
Electrically Guided Bachmann's Bundle Pacing: A Lead Placement Strategy With Potential Antiarrhythmic Benefits

NCT05153291

Sponsor

University of Vermont

Status

Unknown status

Last Update Posted

Mar 9, 2022Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Bachmann's bundle lead placement
Right atrial appendage lead placement

Countries

United States

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2021Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Nov 15, 2021

First Submission Date that Met QC Criteria

Nov 27, 2021

First Posted Date

Dec 10, 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

Mar 8, 2022

Last Update Posted Date

Mar 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

Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bachmann's bundle area pacing	Experimental	Lead placement in Bachmann's bundle area	Procedure: Bachmann's bundle lead placement
Right atrial appendage pacing	Active Comparator	Lead placement in the right atrial appendage	Procedure: Right atrial appendage lead placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bachmann's bundle lead placement	Procedure	Atrial lead placement at Bachmann's bundle area	Bachmann's bundle area pacing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial arrhythmia burden from pacemaker counters	Derived from pacemaker counters and expressed as the average percentage of time per day in atrial fibrillation/tachycardia.	Over 15 month follow up

Secondary Outcomes

Measure	Description	Time Frame
Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups		At implant
Atrial lead procedure time		At implant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is >18 years old
Subject is referred for permanent pacemaker implantation with an indication for an atrial lead
Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration >120ms on a 12-lead ECG)
Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires

Exclusion Criteria:

Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)
Subject has pacemaker implantation prior to planned atrioventricular nodal ablation
Subject has resting spontaneous sinus rate >85 beats-per-minute
Subject has left ventricular ejection fraction <45%
Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
Subject is currently enrolled in a potentially confounding trial
Subject is pregnant
Subject's anticipated life expectancy is less than 1 year

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Vermont Medical Center		Burlington	Vermont	05401	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

De-identified data upon reasonable request

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

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Browse Branches

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