Rate Adaptive Atrial Pacing in Heart Failure | NCT03235843

Studies
Rate Adaptive Atrial Pacing in Heart Failure

NCT03235843

Sponsor

Amsterdam UMC, location VUmc

Status

Unknown status

Last Update Posted

Aug 2, 2017Actual

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Chronotropic Incompetence
Heart Failure
ICD

Interventions

AAIR pacing
DDI-pacing

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Aug 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

Jul 10, 2017

First Submission Date that Met QC Criteria

Jul 27, 2017

First Posted Date

Aug 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2017

Last Update Posted Date

Aug 2, 2017Actual

Name	Class
UMC Utrecht	OTHER
Maasstad Hospital	OTHER
Northwest Clinics Alkmaar	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting.

Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence.

Methods: heart failure patients (left ventricular ejection fraction ≤35% & New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rate Adaptive Pacing ON	Active Comparator	AAIR pacing using a MV sensor	Device: AAIR pacing
Rate Adaptive Pacing OFF	Placebo Comparator	DDI-pacing	Device: DDI-pacing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AAIR pacing	Device	Rate adaptive pacing using a MV sensor.	Rate Adaptive Pacing ON

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of quality of life	Measured with the Minnesota Living with Heart Failure Questionnaire	3 months after changing the pacing mode

Secondary Outcomes

Measure	Description	Time Frame
Improvement of functional capacity	Measured with a six-minute walk test	3 months after changing the pacing mode
Reversibility of chronotropic incompetence	A comparison of the modified HeartRateScore with and without rate adaptive pacing.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
Symptomatic congestive heart failure (NYHA class II-III)
Left ventricular systolic dysfunction (LVEF <35%)
Optimal medical therapy
Sinus rhythm
Subjects should be able to perform normal daily activities

Exclusion Criteria:

Age <18 or incapacitated adult
Documented atrial fibrillation in the last 3 months prior to inclusion
Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
Patients who are unable to tolerate increased pacing rates
Indication for cardiac resynchronization therapy

Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cornelis P Allaart, MD, PhD	Contact	+31 (0)20 4445043		cp.allaart@vumc.nl
Anne-Lotte CJ van der Lingen, MD	Contact	+31 (0)20 4443272		a.vanderlingen@vumc.nl

Overall Officials

Name	Affiliation	Role
Cornelis P Allaart, MD, PhD	Amsterdam UMC, location VUmc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VU university medical center	Recruiting	Amsterdam		1081HV	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21382903	Background	Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases