Assessment of AAIR Pacing Treatment for Heart Failure Patients With Chronotropic Incompetence

NCT03071952 | Completed

• 1 other identifier: CI Study Phase II
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the clinical efficacy of AAIR (Atrial-paced Atrial-sensed Inhibitory Rate-Modulated) pacing treatment for heart failure (HF) patients with chronotropic incompetence (CI) in terms of exercise tolerance and quality of life. Specifically, the study will assess the changes in cardiac function associated with changes of physical exercise intensity and heart rate in AAIR pacing mode compared with AAI pacing mode.

Conditions

Heart Failure

Keywords

Heart Failure; Chronotropic Incompetence; Rate Response; Exercise Test

Outcome Measures

Primary Outcomes (1)

• The treadmill walk duration change

  The treadmill walk duration change from 3-6 months to 6-12 months post pacemaker implantation

Secondary Outcomes (1)

• The 6 minutes hall walk distance change

  3-6 months and 6-12 months post pacemaker implantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In the study, total 30 heart failure patients with chronotropic incompetence who meet the inclusion and exclusion criteria would be enrolled from the ourtpatients in Fuwai Hospital.

You may qualify if:

• Patient is willing to give informed consent.
• Patient is between 18 and 70 years of age (including 18 and 70 years of age).
• Patients can perform treadmill exercise test for at least 8 minutes.
• Patient has been diagnosed with stable chronic HF according to HF guidance, including HFpEF (Heart Failure with preserved Ejection Fraction) and HFrEF (Heart Failure with reduced Ejection Fraction) patients.
• NYHA class I- III, with left ventricular ejection fraction less than 55% and more than 25%.
• Heart rate during treadmill test cannot reach 70% APMHR (Age Predicted Maximal Heart Rate) in (diagnostic criteria for CI, in accordance with class IA indications of pacing therapy for CI).

You may not qualify if:

• Patient with severe liver or kidney dysfunction.
• Patient has contraindications for pacing therapy.
• Patient has CI and is under appropriate clinical therapy.
• Patient has persistent or permanent atrial fibrillation (AF).
• Patient whose heart rate baseline at resting state is greater than 95 beats per minutes (BPM).
• Patient has contraindications for cardio-pulmonary exercise testing, including but not limited to unstable angina, decompensated heart failure, active pericarditis or myocarditis, hypertrophic cardiomyopathy, valvular heart disease and ECG ST-segment shift \> 2mm at resting state.
• Less than 6 months after angina and ST dynamic changes during last 3 months.
• Patient with class I (with PR interval more than 200ms), II or III atrioventricular block, or interventricular block.
• NYHA Class IV.
• Less than 45 days after myocardial infarction.
• Less than 3 months after acute heart failure.
• Patient has uncontrolled hypertension.
• Patient is unwilling to sign the patient informed consent.
• Patient is pregnant or has pregnancy intention in the study duration.
• Patient has a medical condition that would limit study participation.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Shu Zhang, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: March 7, 2017
• Study Start: October 9, 2016
• Primary Completion: November 24, 2017
• Study Completion: November 24, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)