MODULA Modul 7 VRR

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00180414
• Collaborator: Guidant Corporation (Industry)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial fibrillation.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)	N/A

Detailed Description

To investigate whether VRR can increase the amount of biventricular pacing in CRT patients with conducted atrial arrhythmias. Secondarily, an investigation will be carried out to determine whether this increase in biventricular pacing results in an improvement in quality of life, as well as an improvement in the symptoms caused by the atrial arrhythmia and an improvement in the level of physical ability.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: MODULA-Study: Modul 7 VRR: Correlation Between Ventricular Rate Regulation (VRR) and the Percentage of Biventricular Pacing as Well as Subjective Quality of Life and Level of Physical Ability in CRT Patients With Atrial Fibrillation
• Actual Study Start Date: Aug 28, 2004
• Actual Primary Completion Date: May 7, 2008
• Actual Study Completion Date: May 7, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ventricular Rate Regulation feature ON	Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)
Active Comparator: Ventricular Rate Regulation feature OFF	Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)

Outcome Measures

Primary Outcome Measures

1. Percentage of Biventricular Pacing [6 month]

   Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF

Secondary Outcome Measures

1. Correlation Between VRR and the Subjective Quality of Life [6 Month]

   Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups

2. Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias [6 months]

   Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups

3. Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry) [6 months]

   Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients with CRT system with the VRR algorithm

• Patients with permanent atrial fibrillation

• Occasional conducted atrial fibrillation resulting in ventricular rates > 70 beats per minute (bpm)

• QRS complex > 120 ms

Exclusion Criteria:

• Patients with third degree atrioventricular (AV) block

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Lüdenscheid / Kardiologie	Luedenscheid		Germany	58515

Sponsors and Collaborators

• Boston Scientific Corporation
• Guidant Corporation

Investigators

• Principal Investigator: Bernd Lemke, MD, Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00180414
• Other Study ID Numbers: Version vom 10.07.2003 BIS
• First Posted: Sep 16, 2005
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Boston Scientific Corporation: heart failure
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	Ventricular Rate Regulation Feature ON	Ventricular Rate Regulation Feature OFF
Arm/Group Description	CRT devices with ventricular rate regulation [VRR] (CE labeled)	CRT devices with ventricular rate regulation [VRR] (CE labeled)
Period Title: Overall Study
STARTED	4	4
COMPLETED	0	0
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Ventricular Rate Regulation Feature ON	Ventricular Rate Regulation Feature OFF	Total
Arm/Group Description	CRT devices with ventricular rate regulation [VRR] (CE labeled)	CRT devices with ventricular rate regulation [VRR] (CE labeled)	Total of all reporting groups
Overall Participants	4	4	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	NA (NA)	NA (NA)	72.3 (6.5)
Sex: Female, Male (Count of Participants)
Female	1 25%	1 25%	2 25%
Male	3 75%	3 75%	6 75%

Outcome Measures

1. Primary Outcome

Title	Percentage of Biventricular Pacing
Description	Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided.

Arm/Group Title	Ventricular Rate Regulation Feature ON	Ventricular Rate Regulation Feature OFF
Arm/Group Description	CRT devices with ventricular rate regulation [VRR] (CE labeled)	CRT devices with ventricular rate regulation [VRR] (CE labeled)
Measure Participants	0	0

2. Secondary Outcome

Title	Correlation Between VRR and the Subjective Quality of Life
Description	Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups
Time Frame	6 Month

Outcome Measure Data

Analysis Population Description

An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided.

Arm/Group Title	Ventricular Rate Regulation Feature ON	Ventricular Rate Regulation Feature OFF
Arm/Group Description	CRT devices with ventricular rate regulation [VRR] (CE labeled)	CRT devices with ventricular rate regulation [VRR] (CE labeled)
Measure Participants	0	0

3. Secondary Outcome

Title	Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias
Description	Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided.

Arm/Group Title	Ventricular Rate Regulation Feature ON	Ventricular Rate Regulation Feature OFF
Arm/Group Description	CRT devices with ventricular rate regulation [VRR] (CE labeled)	CRT devices with ventricular rate regulation [VRR] (CE labeled)
Measure Participants	0	0

4. Secondary Outcome

Title	Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)
Description	Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

An insufficient number of subjects was enrolled as well as the overall data quality of this investigation did not allow for any conclusions regarding the endpoint. Endpoints were not analyzed, final report does not contain information about analysis. Individual data deleted meanwhile per applicable data storage regulations and unavailable for further analysis, hence detailed results are impossible to be provided.

Arm/Group Title	Ventricular Rate Regulation Feature ON	Ventricular Rate Regulation Feature OFF
Arm/Group Description	CRT devices with ventricular rate regulation [VRR] (CE labeled)	CRT devices with ventricular rate regulation [VRR] (CE labeled)
Measure Participants	0	0

Adverse Events

Arm/Group Title	Ventricular Rate Regulation Feature ON		Ventricular Rate Regulation Feature OFF
Arm/Group Description	CRT devices with ventricular rate regulation [VRR] (CE labeled)		CRT devices with ventricular rate regulation [VRR] (CE labeled)
All Cause Mortality
	Ventricular Rate Regulation Feature ON		Ventricular Rate Regulation Feature OFF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ventricular Rate Regulation Feature ON		Ventricular Rate Regulation Feature OFF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Ventricular Rate Regulation Feature ON		Ventricular Rate Regulation Feature OFF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.