The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT02903940
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 68
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CRT+NAVH	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
• Actual Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CRT+NAVH Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.	Device: CRT+NAVH; Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Outcome Measures

Primary Outcome Measures

1. Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values [1 day]

Secondary Outcome Measures

1. Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Implanted with a functioning SJM Quadripolar CRT Pacing System

• QRS duration > 140 ms

• Left bundle branch block documented

• Ability to provide informed consent for study participation

• Willing to comply with the study evaluation requirements

• At least 18 years of age

Exclusion Criteria:

• CRT Pacing System implanted less than 1 week at time of enrollment

• CRT Pacing System implanted more than 24 months at time of enrollment

• CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms

• Resting ventricular rate >100 bpm

• Intrinsic PR interval > 300 ms

• Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented

• A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator

• Women who are pregnant or who plan to become pregnant during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02903940
• Other Study ID Numbers: CRD_855
• First Posted: Sep 16, 2016
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jan 5, 2022