## Protocol Section
### Identification Module
**NCT ID:** NCT05024279

**Acronym:** PLANET

**Brief Title:** Left Bundle Branch Area Pacing in Patients After TAVR

**Official Title:** Pacing of the Left Bundle Branch Area NEcessitated After TAVR

#### Organization Study ID Info
**ID:** 21-0575
#### Organization
**Class:** OTHER
**Full Name:** Ludwig-Maximilians - University of Munich
### Status Module
#### Completion Date
**Date:** 2025-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-31

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-30

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-08-06

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2021-08-27
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-09
**Study First Submit QC Date:** 2021-08-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ludwig-Maximilians - University of Munich

#### Responsible Party

**Investigator Affiliation:** Ludwig-Maximilians - University of Munich

**Investigator Full Name:** Moritz F. Sinner

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.

**Detailed Description:** Transcatheter aortic valve replacement (TAVR) is a well-established treatment of aortic valve stenosis. Yet, requiry of permanent pacing due to new onset atrio-ventricular conduction block remains a frequent complication. Standard right ventricular pacing (RVP) at high pacing burden may lead to deterioration of left ventricular function. Left-Bundle-Area Pacing (LBBP) is a new, innovative method of physiological ventricular stimulation resulting in narrow, physiological QRS complexes.

In this prospective, randomized, single center clinica trial, patients are included after TAVR and with normal left ventricular function who require pacing due to a higher degree atriao-ventricular block with an anticipated high pacing burden. Patients will be randomized to receive either left bundle branch area pacing (intervention) or right ventricular apical pacing (control).

The results will confirm the feasibility of LBBP in patients following TAVR. Results will further investigate the primary outcome of a clinically relevant QRS narrowing and a combination of exploratory secondary endpoints including clinical outcomes, functional status, laboratory biomarkers, and quality of life.

### Conditions Module

**Conditions:**

- Aortic Valve Stenosis

- AV Block

- Pacing-Induced Cardiomyopathy

**Keywords:**

- left bundle branch area pacing

- av block

- right ventricular pacing

- aortic valve stenosis

- TAVR

- ECG

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 1:1 randomization

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients are randomized to receive left bundle branch are pacing due to higher degree AV block

**Intervention Names:**

- Device: Left bundle branch area pacing

**Label:** Intervention Arm

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients are randomized to receive standard right ventricular pacing due to higher degree AV block.

**Intervention Names:**

- Device: Right ventricular pacing

**Label:** Control Arm

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Arm

**Description:** Left bundle branch area pacing will be applied as established in the literature using commercially available equipment.

In case of unsuccessful application of left bundle branch area pacing, cross-over to right ventricular pacing is allowed.

**Name:** Left bundle branch area pacing

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control Arm

**Description:** Right ventricular pacing as the standard, established form of pacing will be applied in the control group. No cross-over to the intervention arm is anticipated.

**Name:** Right ventricular pacing

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Measure:** Pacemaker-associated complications

**Time Frame:** 3 months

**Measure:** Pacemaker-associated complications

**Time Frame:** 12 months

**Measure:** Pacemaker-associated complications

**Time Frame:** 24 months

**Description:** dichotomous yes / no

**Measure:** procedural implantation success

**Time Frame:** basline

**Measure:** Implantation procedure duration

**Time Frame:** baseline

**Measure:** Fluoroscopy duration

**Time Frame:** baseline

**Measure:** Fluoroscopy dose

**Time Frame:** baseline

#### Primary Outcomes

**Description:** QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads

**Measure:** QRS duration

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads

**Measure:** QRS duration

**Time Frame:** 12 months

**Description:** QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads

**Measure:** QRS duration

**Time Frame:** 24 months

**Measure:** Death of any cause

**Time Frame:** 3 months

**Measure:** Death of any cause

**Time Frame:** 12 months

**Measure:** Death of any cause

**Time Frame:** 24 months

**Measure:** Death of cardio-vascular cause

**Time Frame:** 3 months

**Measure:** Death of cardio-vascular cause

**Time Frame:** 12 months

**Measure:** Death of cardio-vascular cause

**Time Frame:** 24 months

**Measure:** Re-hospitalization due to heart failure

**Time Frame:** 3 months

**Measure:** Re-hospitalization due to heart failure

**Time Frame:** 12 months

**Measure:** Re-hospitalization due to heart failure

**Time Frame:** 24 months

**Measure:** Change in left ventricular ejection fraction

**Time Frame:** 3 months

**Measure:** Change in left ventricular ejection fraction

**Time Frame:** 12 months

**Measure:** Change in left ventricular ejection fraction

**Time Frame:** 24 months

**Measure:** Change in echocardiographic left ventricular enddiastolic diameter

**Time Frame:** 3 months

**Measure:** Change in echocardiographic left ventricular enddiastolic diameter

**Time Frame:** 12 months

**Measure:** Change in echocardiographic left ventricular enddiastolic diameter

**Time Frame:** 24 months

**Measure:** Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency

**Time Frame:** 3 months

**Measure:** Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency

**Time Frame:** 12 months

**Measure:** Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency

**Time Frame:** 24 months

**Measure:** Echocardiographic assessment of right ventricular ejection fraction

**Time Frame:** 3 months

**Measure:** Echocardiographic assessment of right ventricular ejection fraction

**Time Frame:** 12 months

**Measure:** Echocardiographic assessment of right ventricular ejection fraction

**Time Frame:** 24 months

**Measure:** Change in New York heart failure classification status

**Time Frame:** 3 months

**Measure:** Change in New York heart failure classification status

**Time Frame:** 12 months

**Measure:** Change in New York heart failure classification status

**Time Frame:** 24 months

**Measure:** Change in laboratory biomarkers NT-proBNP

**Time Frame:** 3 months

**Measure:** Change in laboratory biomarkers NT-proBNP

**Time Frame:** 12 months

**Measure:** Change in laboratory biomarkers NT-proBNP

**Time Frame:** 24 months

**Measure:** Change in functional status by 6 minute walk

**Time Frame:** 3 months

**Measure:** Change in functional status by 6 minute walk

**Time Frame:** 12 months

**Measure:** Change in functional status by 6 minute walk

**Time Frame:** 24 months

**Measure:** Change in EQ-5D quality of life

**Time Frame:** 3 months

**Measure:** Change in EQ-5D quality of life

**Time Frame:** 12 months

**Measure:** Change in EQ-5D quality of life

**Time Frame:** 24 months

**Measure:** Occurence of arrhythmias

**Time Frame:** 3 months

**Measure:** Occurence of arrhythmias

**Time Frame:** 12 months

**Measure:** Occurence of arrhythmias

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis
* LVEF ≥50%
* Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden \>20%
* Signed informeed conseent to study participation

Exclusion Criteria:

* LVEF \<50%
* Expected pacing burden \<20%
* Pre-existing implanted cardiac device
* Participation in a concurring interventional trial
* age \<18 years
* Current preegnancy
* life expectancy \<6 months

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Munich

**Country:** Germany

**Facility:** LMU Klinikum

**State:** BY

**Zip:** 81377

#### Overall Officials

**Official 1:**

**Affiliation:** LMU Klinikum, Dept. of Cardiology

**Name:** Moritz F Sinner, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** LMU Klinikum, Dept. of Cardiology

**Name:** Stephanie Fichtner, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000082862

- Term: Aortic Valve Disease

- ID: D000006349

- Term: Heart Valve Diseases

- ID: D000014694

- Term: Ventricular Outflow Obstruction

- ID: D000006327

- Term: Heart Block

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000075224

- Term: Cardiac Conduction System Disease

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12154

- Name: Cardiomyopathies

- Relevance: HIGH

- As Found: Cardiomyopathy

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M4340

- Name: Aortic Valve Stenosis

- Relevance: HIGH

- As Found: Aortic Valve Stenosis

- ID: M27765

- Name: Atrioventricular Block

- Relevance: HIGH

- As Found: AV Block

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2379

- Name: Aortic Valve Disease

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17440

- Name: Ventricular Outflow Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: M9415

- Name: Heart Block

- Relevance: LOW

- As Found: Unknown

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M1472

- Name: Cardiac Conduction System Disease

- Relevance: LOW

- As Found: Unknown

- ID: T449

- Name: Aortic Valve Stenosis

- Relevance: HIGH

- As Found: Aortic Valve Stenosis

### Condition Browse Module - Meshes

- ID: D000009202

- Term: Cardiomyopathies

- ID: D000001024

- Term: Aortic Valve Stenosis

- ID: D000054537

- Term: Atrioventricular Block

### Misc Info Module

- Version Holder: 2024-05-24
