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Pacing in First-degree AV-block

Optimal Pacing in Patients With First-degree AV-block

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01985802
Enrollment
20
Registered
2013-11-15
Start date
2015-12-31
Completion date
2017-10-26
Last updated
2017-11-30

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

Conditions

First-degree AV-block, Pacing

Brief summary

The purpose of this study is to explore if there is a less harmful way to pace patients with first-degree AV-block to ensure that the negative effects inferred by the pacing do not outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that His-bundle pacing will offer a more physiological mode of pacing in patients with first-degree AV-block than conventional pacing. Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular ejection fraction will be included. During the AF ablation three different pacing modes (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the completion of all six pacing protocols (i.e., three modes at two different rates) the experimental part of the procedure ends. The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary end-points will include left ventricular ejection fraction, left ventricular volume, mitral regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay. Since the research study is conducted in parallel with the standard catheter ablation, we do not anticipate any additional side effects as a result of the study.

Interventions

OTHERPacing

Sponsors

Medtronic
CollaboratorINDUSTRY
Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for catheter ablation of atrial fibrillation in sinus rhythm and PR prolongation exceeding or equal to 200 ms * QRS duration less than 120 ms * Normal left ventricular ejection fraction on echocardiography.

Exclusion criteria

* Any bundle branch block * Second- or third-degree AV-block * Congestive heart failure, cardiomyopathy, myocardial infarction or major surgical procedure.

Design outcomes

Primary

MeasureTime frame
Echocardiographic evidence of dyssynchrony (AV, intra- or inter-ventricular)During each step of the pacing procedure the echocardiographic data will be recorded; over approximately 5-10 minutes

Countries

United States

Outcome results

None listed

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