## Protocol Section
### Identification Module
**NCT ID:** NCT06436053

**Brief Title:** Acute Response to Left Bundle Branch Area Pacing With SyncAV

**Official Title:** Acute Response to Left Bundle Branch Area Pacing With SyncAV

#### Organization Study ID Info
**ID:** ABT-CIP-10516
#### Organization
**Class:** INDUSTRY
**Full Name:** Abbott Medical Devices
### Status Module
#### Completion Date
**Date:** 2026-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Abbott Medical Devices

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left bundle branch area pacing (LBBAP).

### Conditions Module

**Conditions:**

- Heart Failure

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: LBBAP with SyncAV

**Label:** LBBAP with SyncAV

### Interventions

#### Intervention 1

**Arm Group Labels:**

- LBBAP with SyncAV

**Description:** Acute changes in surface ECG QRS duration resulting from left bundle branch area pacing using various pacing configurations will be evaluated.

**Name:** LBBAP with SyncAV

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Acute change in surface ECG QRS duration resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.

**Measure:** QRS duration

**Time Frame:** During the intervention/procedure/surgery

#### Secondary Outcomes

**Description:** Acute change in left ventricular hemodynamics (i.e., maximum rise in pressure) resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.

**Measure:** LV hemodynamics

**Time Frame:** During the intervention/procedure/surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patient is 18 years of age and willing to comply with the study requirements
2. Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an Abbott pacing system
3. Patient has documented left bundle branch block (LBBB) or intraventricular conduction delay (IVCD)
4. Patient has an intrinsic QRS duration ≥ 130 ms
5. Patient has intact AV conduction with PR interval ≤ 250 ms

Exclusion Criteria:

1. Patient has a resting ventricular rate \> 100 bpm
2. Patient has AV Block (2nd or 3rd degree)
3. Patient has documented persistent atrial tachycardia or atrial fibrillation
4. Patient has had a recent myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacing device programming changes in the opinion of the investigator
5. Patient is currently participating in another clinical investigation
6. Patient is pregnant or nursing
7. Patient has other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
8. Patient does not have legal authority
9. Patient is unable to read or write

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy, with documented left bundle branch block or intraventricular conduction delay, long QRS duration, and intact AV conduction will be enrolled.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nima.badie@abbott.com

**Name:** Nima Badie, PhD

**Phone:** 408-702-8604

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** San Donato Milanese

**Contacts:**

***Contact 1:***

- **Email:** Carlo.pappone@grupposandonato.it

- **Name:** Carlo Pappone, MD, PhD

- **Phone:** +39 -0252774260

- **Role:** CONTACT

**Country:** Italy

**Facility:** I.R.C.C.S. Policlinico San Donato

**State:** MI

**Status:** RECRUITING

**Zip:** 20097

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
