Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06474819

Acronym

DEEP

Enrollment

326

Registered

2024-06-26

Start date

2024-07-12

Completion date

2027-01-12

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Heart Block, Second Degree Atrioventricular Block Möbitz Type II

Brief summary

Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages. Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.

Interventions

DEVICEPacemaker implant

All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (\<45lpm). * LVEF\>50% at echocardiography performed maximum 7 days before pacemaker implant. * Informed consent signature.

Exclusion criteria

* Life expectancy \<12 months * Severe cardiac valvular abnormality requiring intervention * Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant. * Inclusion in another trial which may influence the results of this study.

Design outcomes

Primary

Measure	Time frame	Description
Pacing-induced cardiomyopathy	12 months	Decrease in the left ventricular ejection fraction (LVEF) by \>10% as compared to the LVEF before pacemaker implant and final LVEF\<45%.

Secondary

Measure	Time frame	Description
LVEF during follow-up	12 months	To compare the mean or median (depending on distribution) LVEF before and one year after pacemaker implant in the two groups.
Mitral and tricuspid regurgitation	12 months	To compare the degree of mitral and tricuspid regurgitation before and one year after pacemaker implant in the two groups.
Brain Natriuretic Peptide levels	12 months	To compare the N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels one year after pacemaker implant in the two groups.
heart failure	12 months	Comparison of heart failure (HF) events in the first year after pacemaker implant in the two groups. HF events will be: hospitalizations for heart failure, emergency department or day-hospital visits for heart failure, heart failure symptoms requiring the initiation of diuretic therapy.
New York Heart Association (NYHA) class	12 months	To compare the NYHA class one year after pacemaker implant in the two groups.

Other

Measure	Time frame	Description
Complications	12 months	Complications related to the ventricular lead

Countries

Spain

Contacts

Primary ContactAndrea Di Marco, MD, PhD

adimarco@bellvitgehospital.cat+34932 60 75 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026