BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Hypertension Clinical Trial

— BACKBEAT  

Official title:

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059638
• Other study ID #: CS-08
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2023
• Est. completion date: June 2028

Study information

• Verified date: June 2024
• Source: Orchestra BioMed, Inc
• Contact: Hans-Peter Stoll, MD, PhD
• Phone: 646-956-2161
• Email: hpstoll[@]orchestrabiomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG.

Description:

The study will be conducted in three phases: 1) Screening/ Run-in Phase, 2) Double-blind Randomized phase (1 year), and 3) Randomized unblinded phase (2 years). Patients within 90 days of de novo implant of a Medtronic Astra/Azure pacemaker also having uncontrolled hypertension may be approached for inclusion into this study. During the Double-blind Randomized Phase, subjects in the control group will receive standard-of-care pacemaker and hypertension therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2028
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Within 90 days of a de novo implant of a Medtronic Astra/Azure dual chamber pacemaker and Medtronic pacing leads

2. On a stable antihypertension treatment regimen with 1, 2 or 3 classes of antihypertensive drugs

3. Office SBP =140 mmHg and <180 mmHg

4. Average 24-Hour aSBP =130 mmHg and <170 mmHg

Exclusion Criteria:

1. LVEF <50%

2. NYHA Class II-IV

3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months

4. Myocardial infarction (MI) within 3 months

5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months

6. Persistent or permanent atrial fibrillation

7. Mitral valve regurgitation greater than 2+

8. Aortic stenosis with a valve area less than 1.5 cm2

9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)

10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Related Conditions & MeSH terms

• Bradycardia
• Essential Hypertension
• Hypertension
• Hypertension, Systolic
• Hypertension,Essential
• Isolated Systolic Hypertension

Intervention

Device:
• Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
• Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated

Locations

Country	Name	City	State
Belgium	OLV Hospital Aalst	Aalst
Czechia	Na Homolce Hospital	Prague
Hungary	Semmelweis University	Budapest
Spain	Hospital La Paz	Madrid
United States	Piedmont Healthcare, Inc.	Atlanta	Georgia
United States	The Johns Hopkins University	Baltimore	Maryland
United States	The Cooper Health System	Camden	New Jersey
United States	The Lindner Research Center	Cincinnati	Ohio
United States	OhioHealth Corporation	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Citrus Cardiology Consultants	Crystal River	Florida
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Stern Cardiovascular Foundation, Inc.	Germantown	Tennessee
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Baptist Health Jacksonville	Jacksonville	Florida
United States	Virtua Medical Group, P.A.	Marlton	New Jersey
United States	Northwell Health, Inc.	New Hyde Park	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	The Valley Hospital	Ridgewood	New Jersey
United States	HonorHealth	Scottsdale	Arizona
United States	West Houston Area Clinical Trial Consultants (Wichita, KS)	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Orchestra BioMed, Inc	Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Hungary,  Spain, 

References & Publications (2)

Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13. — View Citation

Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months	Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization	Baseline and 3 months post randomization
Primary	Freedom from Unanticipated Serious Adverse Device Effects (USADE)	Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.	3 months post randomization