ACC - Atrial Contribution to CRT

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00180323
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arm: 1
• Duration (Months): 49
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the resynchronised ventricles in the event of right atrial pacing.

Condition or Disease	Intervention/Treatment	Phase
Dilated Cardiomyopathy	Device: Renewal	N/A

Detailed Description

All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ACC - Atrial Contribution to CRT
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Renewal CRT (CRT ICD) Single arm study only. All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI (Velocity Time Integral) measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Device: Renewal; Renewal is a CRT-D device for cardiac resynchronization therapy

Outcome Measures

Primary Outcome Measures

1. Aortic Velocity Time Integral (VTI) [At implant (baseline), 3 months and 6 months Follow-up]

   Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).

2. Optimal AV-Delay (AVD) [Implant (baseline), 3 months and 6 months Follow-up]

   Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.

Secondary Outcome Measures

1. 6 Minute Walk Test [implant (baseline), 3 months and 6 months Follow-up]

   6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.

2. Left Ventricular Ejection Fraction (LVEF) [implant (baseline), 3 Months, 6 Months]

   Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Symptoms of heart failure

• Left ventricular dysfunction

• Ventricular dyssynchrony

• 18 years or of legal age in order to give informed consent according to national laws

• Able to understand the nature of the procedure

• Available for follow-up on a regular basis at an approved investigational center

Exclusion Criteria:

• Atrial Fibrillation

• Life expectancy of less than six months due to other medical conditions

• For women: pregnancy or absence of medically accepted birth control

• Inability or refusal to sign the Patient Informed Consent

• Inability or refusal to comply with the follow up schedule or protocol requirements

• Inability to undergo device implant, including general anaesthesia if required

• Mechanical tricuspid prosthesis

• Currently enrolled in another investigational study, including drug investigations

• Hypertrophic Obstructive Cardiomyopathy (HOCM)

• Not meeting the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Jasper Hastrup Svendson, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00180323
• Other Study ID Numbers: ACC Version 1.1 11/09/2003
• First Posted: Sep 16, 2005
• Last Update Posted: Feb 11, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated

Study Results

Participant Flow

Arm/Group Title	Group 1
Arm/Group Description
Period Title: Overall Study
STARTED	43
COMPLETED	43
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description
Overall Participants	43
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 65.1%
>=65 years	15 34.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (11)
Sex: Female, Male (Count of Participants)
Female	12 27.9%
Male	31 72.1%
Region of Enrollment (participants) [Number]
Denmark	43 100%

Outcome Measures

1. Primary Outcome

Title	Aortic Velocity Time Integral (VTI)
Description	Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).
Time Frame	At implant (baseline), 3 months and 6 months Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Resynchronization Therapy ICD (Renewal CRT)
Arm/Group Description	Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
Measure Participants	43
VTI at baseline intrinsic rhythm	22.4 (7.7)
VTI at baseline intrinsic rhythm + 10 Bpm	21.7 (7.7)
VTI at baseline intrinsic rhythm + 20 Bpm	19.4 (7.5)
VTI at baseline intrinsic rhythm + 30 Bpm	18.1 (7.1)
VTI at 3M Follow-up intrinsic rhythm	23.6 (9.0)
VTI at 3M Follow-up intrinsic rhythm + 10 Bpm	21.9 (9.0)
VTI at 3M Follow-up intrinsic rhythm + 20 Bpm	21.2 (8.1)
VTI at 3M Follow-up intrinsic rhythm + 30 Bpm	19.4 (8.3)
VTI at 6M Follow-up intrinsic rhythm	24.6 (8.4)
VTI at 6M Follow-up intrinsic rhythm + 10 Bpm	23.2 (7.5)
VTI at 6M Follow-up intrinsic rhythm + 20 Bpm	21.7 (7.0)
VTI at 6M Follow-up intrinsic rhythm + 30 Bpm	20.2 (7.2)

2. Primary Outcome

Title	Optimal AV-Delay (AVD)
Description	Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
Time Frame	Implant (baseline), 3 months and 6 months Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Resynchronization Therapy ICD (Renewal CRT)
Arm/Group Description	Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
Measure Participants	43
Optimal AVD at baseline intrinsic rhythm	115 (24)
Optimal AVD at baseline intrinsic rhythm +10Bpm	119 (29)
Optimal AVD at baseline intrinsic rhythm +20Bpm	123 (22)
Optimal AVD at baseline intrinsic rhythm +30Bpm	127 (28)
Optimal AVD at 3M intrinsic rhythm	117 (28)
Optimal AVD at 3M intrinsic rhythm +10Bpm	117 (24)
Optimal AVD at 3M intrinsic rhythm +20Bpm	127 (28)
Optimal AVD at 3M intrinsic rhythm +3Bpm	119 (23)
Optimal AVD at 6M intrinsic rhythm	115 (24)
Optimal AVD at 6M intrinsic rhythm +10Bpm	132 (28)
Optimal AVD at 6M intrinsic rhythm +20Bpm	130 (30)
Optimal AVD at 6M intrinsic rhythm +30Bpm	130 (17)

3. Secondary Outcome

Title	6 Minute Walk Test
Description	6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.
Time Frame	implant (baseline), 3 months and 6 months Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Resynchronization Therapy ICD (Renewal CRT)
Arm/Group Description	6 minute walktest (6 MWT) was performed before implant (baseline ), 3months and 6 months Follow-up.
Measure Participants	43
6 MWT at baseline	388 (88)
6 MWT at 3M Follow-up	470 (87)
6 MWT at 6M Follow-up	497 (83)

4. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up
Time Frame	implant (baseline), 3 Months, 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Resynchronization Therapy ICD (Renewal CRT)
Arm/Group Description	Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
Measure Participants	43
LVEF at baseline	21 (6)
LVEF at 3M	24 (7)
LVEF at 6M	24 (8)

Adverse Events

Time Frame	Adverse events were assessed only at implant, 3 months and 6 months follow-up. Events observed between these visits were not provided by the investigator.
Arm/Group Title	Group 1
Arm/Group Description
All Cause Mortality
	Group 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/43 (0%)
Other (Not Including Serious) Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.